Annual Report - Breast Cancer Institute of Australia

Transcription

Annual Report
1 April 2010 - 31 March 2011
ANZ Breast Cancer Trials Group Limited
Registered Address:
Level 2
NBN Telethon Mater Institute
82 Platt Street
WARATAH NSW 2298
AUSTRALIA
Telephone:
Business Administration Department: (+61) 2 4925 5255
Trials Coordination Department: (+61) 2 4985 0136
Web: www.anzbctg.org
ACN 051 369 496
ABN 64 051 369 496
ATO N0939
Breast Cancer Institute of Australia
Fundraising and Education Department of the
ANZ Breast Cancer Trials Group Ltd
Telephone: (+61) 2 4925 3022
Web: www.bcia.org.au
©2011 This report cannot be reproduced without the permission of the
ANZ Breast Cancer Trials Group Ltd. All rights reserved.
Contents
Contents
1
Chairman’s Report
3
Chief Operating Officer’s Report
5
Research Report
7
Research Achievements and Highlights
11
Clinical Trials Open for Patient Entry
19
Prevention Trials
19
Local and Systemic Therapy Trials
22
Clinical Trials Completed
35
Communication Report
41
Consumer Advisory Panel Report
43
Fundraising and Education Report
45
Fundraising Achievements and Highlights
47
Governance and Footprint
59
Contributors, Members and Supporters
67
Financial Report
85
Publications
91
Glossary of Terms
95
ANZBCTG Annual Report 2010-2011
1
The Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) conducts Australia’s only independent,
national breast cancer clinical trials research program for the treatment, prevention and cure of breast cancer.
The research program involves multicentre national and international clinical trials and brings together over 500
researchers in 78 institutions throughout Australia and New Zealand. Working together, resources are pooled
so that important research questions can be answered sooner, and with greater scientific integrity for the
benefit of women.
The ANZBCTG has made, and continues to make, significant contributions to the control of breast cancer and
these are highlighted throughout this report.
Our Mission: Our Vision: Our Values:
To eradicate all suffering from breast cancer through the highest quality clinical trials research.
To be a global and regional leader in research
collaboration committed to a world without breast cancer.
Excellent, relevant, transparent, reputable,
inclusive, innovative.
ANZBCTG Trials Coordination Department Staff at the 2010 Annual Scientific Meeting in Sydney.
2
Chairman’s Report
This is my sixth year as Chair of the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) and
I continue to really appreciate the opportunity to contribute to the Group and its commitment to a “world
without breast cancer”.
The ANZBCTG has had another excellent year in clinical trials activity and in our financial position, and I
am excited to introduce the Group’s new logo in this Annual Report. The new logo has been developed to
symbolise the evolving identity, values and ‘personality’ of the ANZBCTG in the 21st century. Its design is
intended to recognise all of our dedicated supporters. These include our researchers and their significant
scientific contributions to treatment breakthroughs, women who have participated in our trials, without whom
progress would not have been possible, and all those from the community who generously support our work
through the Breast Cancer Institute of Australia (BCIA) as a donor or sponsor. I hope you like the logo as
much as we do. Other highlights for the year have been:
■■
39 new journal publications of research results, with the total number of published papers exceeding 800
since the Group’s inception;
■■
growth in staff capacity to more than 60 personnel;
■■
the Annual Scientific Meeting held jointly with the Clinical Oncological Society of Australia in Melbourne; and
■■
commencement of the Group’s Communications Plan.
It is with sadness that I report that this year also saw the resignation of Ms Wendy Carmichael, our Chief
Operating Officer (COO). Wendy has been an integral part of the ANZBCTG for 13 years. For the last four
years as COO, she has expertly led the Group with her wisdom and good humour during a time of major
change and development. On behalf of myself and the Board, I thank Wendy for a truly great contribution
to the Group. It has been a pleasure to work with her. On behalf of the ANZBCTG, I welcome our new
COO, Dr Soozy J Smith, who recently started with the Group. Soozy has extensive leadership experience in
business development and in building relationships. We look forward to working with her.
Governance
I was re-elected Chair of the ANZBCTG for a further three years in July 2009 (this will be my last term) and it
has been an honour to continue my association with the Group’s dedicated staff and volunteers. The Board
continues to broaden and strengthen its skill set and the transition from nine elected Directors to six elected
Directors, and up to three appointed Directors, is now complete.
Mr Stephen Porges and Mr Michael Hamar have been appointed as Directors to the Board and bring a
wealth of experience in business and the banking sector. We look forward to working with them and to
their contributions to our activities. Stephen is also Chair of the newly established Communications and
Fundraising Subcommittee (CFC). Melinda Conrad retired as an appointed Director during the reporting
period and we thank her for her valuable input and welcome her continued involvement in our activities via
her membership of the CFC. Our third appointed Director is Professor Stephen Ackland who continues to
contribute his many medical, political, networking and commonsense skills to the Board and his base in
Newcastle is also much appreciated. He is also a member of the Finance and Audit Subcommittee.
Associate Professor Fran Boyle retired from her five year position as Chair of the Scientific Advisory
Committee (SAC). Fran has made a major contribution during this time and we are very appreciative of her
commitment to the Group. She will remain as Vice Chair of SAC and has also been elected Deputy Chair of
the Board of Directors. Associate Professor Nicholas Wilcken from Westmead Hospital has been appointed
Chair of SAC and brings with him wide experience in oncology clinical trials including long involvement with
the ANZBCTG through his membership of SAC.
3
Strategic Planning
The ANZBCTG’s Strategic Planning Framework underpins the Group’s goals over the five year period from
2009-2014 and outlines our priority activities to achieve these goals. In this the second year of the planning
framework, there has been a focus on branding and key stakeholder confidence.
Following the appointment last year of our Communications Manager, Anna Fitzgerald, a Communications
Plan for the Group has been finalised. This plan has been developed to establish routine processes
that support appropriate, efficient and valued two way communication between the Group and all of its
stakeholders. The communication survey to members undertaken earlier this year will be used to further
develop and refine these processes and the support the Group provides to its members.
Financial Position
As the Group continued its very healthy financial position during the reporting period (April 2010 –
March 2011) the Board implemented an investment policy in early 2011. We have been successful in
our submissions for funding from the National Health and Medical Research Council and other grants,
pharmaceutical support for specific clinical trials and ongoing support from valued donors and corporate
sponsors, particularly Avon and the Commonwealth Bank, through the BCIA. The work of the BCIA is
particularly important to the Group as it underpins our ability to fund otherwise unfunded initiatives including
the startup of locally developed protocols and international studies.
For more information on the ANZBCTG’s financial position please refer to the Financial Report on page 85.
The Future
This is an exciting time for the ANZBCTG. As a result of the foundations and planning laid out in recent years,
the Group is in a strong position as we look to the future. The year ahead will see the implementation of
the Communications Plan and a further strengthening of our brand. As we continue to follow our Strategic
Planning Framework, our goal is to be in a position to fully fund trials.
We remain committed to our values to be excellent, relevant, transparent, reputable, inclusive and innovative,
and to make significant contributions to the prevention and treatment of breast cancer and the quality of life
of women, through the highest quality clinical trials research.
Dr Jacquie Chirgwin
Chairman, Board of Directors
4
Chief Operating
Officer’s Report
The 2010/2011 ANZBCTG Annual Report marks the launch of a new logo and branding strategy for the
Group. As you can see we have retained the most important element of our original logo – the DNA strand –
but have modernised its design and introduced pink, the universally recognised colour of breast cancer
awareness. Updating our logo, website and corporate materials is part of the Group’s Communications Plan
and one of the key objectives from our current Strategic Planning Framework.
Research Program
The ANZBCTG clinical trials research program reached new heights, our hard working Scientific Advisory
Committee (SAC) reviewed more projects than ever resulting in exciting new research initiatives. New staff
appointments have been made and further capacity building within the Trials Coordination Department is
planned for 2011/2012 to manage our increasing portfolio of activities.
Associate Professor Fran Boyle completed her five year tenure as Chair of the ANZBCTG SAC. Associate
Professor Boyle achieved a great deal during her Chairmanship: introducing SAC Subcommittees to increase
member involvement in scientific decision making processes and to foster new research concepts; attracting
new committee members; developing succession planning processes; and championing ANZBCTG
discretionary funding mechanisms. Fran’s enthusiasm, pragmatism, humour and commitment have been
key to her success and her continuation as Vice Chair of the SAC will greatly assist the Committee. Fran is
succeeded by Associate Professor Nicholas Wilcken, a medical oncologist and researcher from Westmead
Hospital in Sydney. Nicholas has been a member of the SAC for some years, and we wish him well in his
new appointment.
Operations
Operationally the Group has thrived, year two of our current five year Strategic Planning Framework is
complete and we are on track to achieve all of the objectives set by the Board of Directors. The clear
direction provided by the Framework enables the ANZBCTG to more effectively pursue its mission and
efficiently allocate its resources. Many new opportunities are being realised and the Group’s relationships with
key stakeholders are being strengthened.
The ANZBCTG completed the financial year in a strong position. The ANZBCTG Board of Directors initiated
an investment policy to help the Group manage its cash reserves and to ensure appropriate returns on these
reserves are realised, to help support the Group’s strategic directions and build an endowment. The Group
was independently audited following the closure of the financial year and the surplus reported is committed
to current and future ANZBCTG research projects. I would like to acknowledge the support we receive from
Cancer Australia through the Support for Clinical Trials program (this funding has recently been secured
for a further three years) and from our donors, corporate sponsors and other funding partners. For more
information on the Group’s financial position please refer to the Financial Report on page 85.
We were also awarded additional competitive research grants which are administered on behalf of the
ANZBCTG by the University of Newcastle and other administering institutions. Likewise, the Group received
infrastructure funding from the Cancer Institute NSW.
Goodbye
This is my final report as Chief Operating Officer of the ANZBCTG. After more than 13 years with the Group
I am moving on. It is a bittersweet moment for me - I will greatly miss the community of the ANZBCTG and
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most of all my hard working, dedicated and supportive staff members. I have no doubt the Group, and those
who tirelessly contribute to it, will go from strength to strength and the results of our research program will
help all those affected by breast cancer. I have gained so much, both professionally and personally, from my
time with the ANZBCTG and I wish everyone all the very best for the future.
Wendy Carmichael
Chief Operating Officer
6
Research
Report
The year in review has seen continued progress in the design, conduct, analysis and publication of our clinical
trials. New trials were launched, others reached recruitment goals and results from research the ANZBCTG
has contributed to were published and will be translated into improved treatment options for women with or
at risk of breast cancer.
It has been particularly pleasing that through improved processes within the Scientific Advisory Committee
(SAC) and the Trials Coordination Department (TCD), and the opportunity for members to access ANZBCTG
discretionary funding, solid foundations have been laid to encourage and support our clinical members to
develop, plan and initiate research concepts that are consistent with the scope and strategic direction of the
ANZBCTG research program. Examples include the SORBET and PROSPECT trials which are now open for
participant entry.
This, together with our significant international collaborations and peer-reviewed continuous grant support,
including from the National Health and Medical Research Council, underpins the ANZBCTG commitment
to designing and conducting clinical trials to the highest standards, and ensuring that the outcomes from
research have the potential to benefit all women.
Trial Activity and Recruitment
During the reporting period 13 clinical trials and four substudies were open for participant entry, two new
trials initiated by ANZBCTG members commenced and three new trials were under development. Five trials
completed accrual and these include the global trial ALTTO which investigates lapatinib and trastuzumab;
TAILORx, which we joined late but are eagerly awaiting the results (this study included a test on breast cancer
tissue to predict potential benefit from chemotherapy added to hormonal treatment); the SOFT and TEXT
trials and the Co-SOFT substudy.
Our research program relies on the support of women who volunteer to take part in our clinical trials and
the role of our researchers who invite them to participate. For the LATER study, the ANZBCTG introduced a
new recruitment strategy, a video, which can be viewed on the website. This, together with other prevention
recruitment strategies has helped to identify, inform and invite women who may be eligible to consider
participating in our prevention trials. The introduction of a Communications Plan for the ANZBCTG will further
help us to support the dedicated study coordinators and investigators at our participating institutions to
recruit women to our clinical trials program.
The ANZBCTG membership continues to grow with over 500 active members from throughout Australia and
New Zealand helping to recruit 457 new participants to our clinical trials program during the reporting period.
This brings the number of women who have participated in ANZBCTG research to more than 13,000. Five
new institutions joined our research program which will provide more women with access to clinical trials.
Annual Scientific Meeting
The ANZBCTG Annual Scientific Meeting remains a very important activity of the Group. In 2010 we had the
opportunity to hold two meetings, the first in Sydney in July, and the second in conjunction with the Clinical
Oncological Society of Australia conference in Melbourne in November.
Both meetings provided important access for our members to international and national experts in breast
cancer who shared their research knowledge and experiences. Specialised workshops, forums and other
discussion and networking opportunities ensured these meetings were very worthwhile for all in attendance.
7
Achievements and Priorities
During the reporting period, 39 new publications were added to the ANZBCTG peer-reviewed publication
portfolio. As new trials begin, other trials reach their accrual targets, progress into follow-up phase and data is
prepared for analysis and publication.
The global accrual targets for the SOFT and TEXT clinical trials were achieved early in 2011, with more
than 3,000 women enrolled in SOFT and over 2,500 in TEXT. More than 480 women from Australia and
New Zealand were enrolled in these studies. The outcomes from these trials, which focus on the ovarian
suppression question, are very important for young, premenopausal women with hormone-sensitive breast
cancer, who may have a poorer long term prognosis despite receiving chemotherapy. A planned efficacy
analysis will review results across both trials.
The Co-SOFT substudy, led by the ANZBCTG, completed accrual during the reporting period. It is known
that oestrogen has an important role in brain function, and this substudy will evaluate the cognitive function of
women participating in the SOFT trial who receive treatments to suppress this hormone.
Women who have been diagnosed with breast cancer may have a risk of recurrence of 1-3% per year, long
term. The ANZ 0501 LATER study aims to reduce this high long term risk and improve long term surveillance.
This study will be open for participant entry until the end of February 2012 and new recruitment strategies are
being piloted for this population.
Several clinical trials are now collecting longer term follow-up data that we hope will lead to a better
understanding of the benefit of breast cancer treatments. ANZBCTG researchers have committed to
collecting longer term follow-up data for two trials. The LATTE (Long-term Anastrozole vs Tamoxifen
Treatment Effects) trial commenced during the reporting period and will continue to collect data for up to
15 years post diagnosis from participants who received either anastrozole or tamoxifen as part of their
participation in the ATAC (Arimidex®, Tamoxifen Alone or in Combination) trial. Data will also be collected until
2015 from women, including many enrolled from Australia and New Zealand, who received letrozole and/or
tamoxifen while participating in the Breast International Group 1-98 trial. The data that is collected will lead to
new strategies for use in the systemic therapy setting.
New Trial Initiatives
To further understand the biology of breast cancer and achieve the goal of selecting treatment strategies
likely to benefit patients, the ANZBCTG is coordinating trials that evaluate multiple therapies, combinations of
therapies and biomarkers.
A new, large international clinical trial for women newly diagnosed with a type of breast cancer called
HER2-positive will commence in 44 countries around the world including Australia and New Zealand in
late 2011. The current standard treatment for women with HER2-positive breast cancer is a drug called
trastuzumab (Herceptin®). This treatment was proven effective by an earlier clinical trial, which our researchers
contributed to, called HERA. This new clinical trial, called APHINITY, will build on this research. Women who
take part will receive treatment with trastuzumab, or with trastuzumab and a new drug called pertuzumab.
These two drugs are complementary and it is hypothesised that the combination may provide a more
comprehensive blockage of the HER2 signalling pathways than either drug alone, and will further improve
outcomes for women with HER2-positive breast cancer.
Women diagnosed with breast cancer and who also have inherited an abnormality in one of the breast
cancer predisposition genes, BRCA1 or BRCA2, develop breast cancers which do not repair damaged
DNA (genes) normally. A type of breast cancer called triple-negative may also fail to repair DNA normally and
women diagnosed with this type of breast cancer have fewer treatment options. PARP is an enzyme that
repairs broken DNA in cells. Chemotherapy can damage DNA in cancer cells causing the cells to die, but
PARP may repair the damaged genes in the cancer cell, thus reversing the effect of the chemotherapy and
allowing the cancer cells to divide and grow. PARP inhibitors enhance the effect of chemotherapy and can
improve outcomes for women with types of breast cancer that have been very difficult to manage. ANZBCTG
researchers have initiated an important phase I study called PRISM which will investigate the PARP inhibitor
olaparib in combination with chemotherapy. PRISM is in the study development phase.
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Many women with breast cancer will receive an aromatase inhibitor (AI) as part of their treatment. This may
be for the prevention of recurrence following surgical treatment of early breast cancer or for the control of
advanced breast cancer. Unfortunately, some women experience symptoms such as joint pain and stiffness
while receiving treatment with an AI, which can make continuing the treatment difficult. Others will continue
but with a heavy impact on their quality of life. A new clinical trial initiated by ANZBCTG researchers and now
under development, called GALA, aims to determine whether glucosamine sulphate can reduce the severity
of these muscle and joint symptoms and whether this can in turn reduce the rate of discontinuation of
treatment with the AI, letrozole.
It is generally thought that women having chemotherapy should avoid infusions in the arm on the same side
as their breast surgery and axillary nodes. However, there is no evidence to support this, and women may be
subjected to unnecessary central venous catheters because of reluctance to use that arm. A new pilot study,
initiated by ANZBCTG investigators, called SCUBA, will systematically document the rate of lymphoedema by
a variety of objective techniques and subjective instruments in women receiving chemotherapy in either arm
following breast conservation surgery and the newer technique of sentinel node biopsy.
Other clinical trials under consideration will investigate key issues pertaining to local therapy for older women
with early breast cancer to inform individualised best practice. Important translational research initiatives to
investigate the biological nature of breast cancer will continue. We have learned much more about how to
‘tailor’ treatments to particular types of breast cancer. The new trial initiatives described above will provide
ANZBCTG researchers and their patients continuing access to evidence based treatments, maintain high level
global and clinical trials activity and promote innovative ideas from clinicians in Australia and New Zealand.
In Summary
Treatment for women with breast cancer and prevention of this disease must be based on the most
reliable science. Breast cancer research continues to produce important, new information to improve our
understanding of breast cancer biology. This can lead to effective, safe and unique treatment for every
woman diagnosed with breast cancer.
The ANZBCTG research strategy remains focussed and clear – national and international collaboration
with the best researchers to generate relevant and high quality data. This is the proven pathway to further
progress and better outcomes for women.
Professor John F Forbes Director of Research
Associate Professor Nicholas Wilcken
Chair, Scientific Advisory Committee
Associate Professor Fran Boyle Vice Chair, Scientific Advisory Committee
Mrs Dianne Lindsay
Head of Trials Management
9
10
Research Achievements
and Highlights
The ANZBCTG research program encompasses more than 60 clinical trials in various stages of recruitment,
follow-up, analysis and publication.
Currently, there are over 500 active ANZBCTG members, representing 78 institutions throughout Australia
and New Zealand. Please refer to page 70 for further details.
Research achievements and highlights during the reporting period have been considerable and are
summarised below.
Clinical Trials Program
During the reporting period the ANZBCTG had a record 17 breast cancer clinical trials including substudies
open for participant entry, and recruited 457 new participants to its clinical trials research program. This
has been achieved due to the dedicated research staff in the ANZBCTG Trials Coordination Department,
the commitment of our members and their research teams at ANZBCTG participating institutions, and the
support of our generous donors and sponsors.
We were pleased to approve the participation of five new institutions in the ANZBCTG research program
- Cairns Base Hospital in Queensland, Royal Darwin Hospital in the Northern Territory, Newcastle Private
Hospital in New South Wales, Ballarat Health Services in Victoria and Mersey Community Hospital in Tasmania.
Two new trials, ANZ 1001 SORBET and ANZ 1002 PROSPECT, were opened during the reporting period.
Both of these trials were initiated by ANZBCTG researchers and we anticipate that the results of these trials
will produce important, new information to improve outcomes for women diagnosed with invasive breast
cancer. An international substudy to the SOLE trial (SOLE-EST) and a new trial to extend the duration of long
term follow-up of ATAC trial participants were also opened. These clinical trials are summarised below. For
more information please refer to Clinical Trials Open for Patient Entry on page 19.
ANZ 1001 SORBET
This new clinical trial aims to improve outcomes for women with triple-negative metastatic breast cancer,
using the highly effective drug for hormone-sensitive breast cancer, tamoxifen. Currently, women with
triple-negative breast cancer are treated with standard chemotherapy which can have benefits but which is
also associated with significant side effects. Only one form of the oestrogen receptor, oestrogen receptor
alpha (ERα), is routinely tested at present to determine whether the breast cancer is ER-positive, or not.
Researchers have discovered that another form of the receptor, called oestrogen receptor beta (ERβ), may
be a predictive marker for response to tamoxifen. This receptor will be measured in the SORBET study and
women whose tumours have that receptor will be treated with tamoxifen. If tamoxifen improves outcomes for
women with ERβ-positive metastatic breast cancer, another important, simple, inexpensive treatment option
will become available for these women.
ANZ 1002 PROSPECT
Thousands of women with early invasive breast cancer undergo breast radiotherapy each year after their
surgery has been completed. Prior attempts to identify subsets of women who can safely avoid radiotherapy
11
have failed. The PROSPECT pilot study will use a new technology, breast magnetic resonance imaging, to
help identify a group of women with a low risk of breast cancer recurrence for whom radiotherapy treatment
may be safely omitted. Outcomes from this trial could significantly alter the management of women with early
invasive breast cancer as well as decrease costs to the health care system.
SOLE-EST
SOLE is an international trial which will evaluate the effectiveness of extending the duration of hormone
treatment for women who are postmenopausal, were diagnosed with hormone-sensitive breast cancer more
than four years ago and who have completed treatment with tamoxifen and/or an aromatase inhibitor. Longer
term hormone treatment may reduce the risk of breast cancer recurrence and for this trial will include letrozole
taken daily for five years, or with a series of three month gaps in treatment. The substudy SOLE-EST will
investigate changes in hormone levels during the three month gap periods as well as changes to grip strength.
LATTE
Long term follow-up of women who participate in breast cancer clinical trials is important. It leads to improved
understanding of the longer term benefits of breast cancer treatment. The ANZBCTG is participating in the
LATTE (Long-term Anastrozole vs Tamoxifen Treatment Effects) trial which will continue the collection of data
for up to 15 years post breast cancer diagnosis from patients who received either anastrozole (Arimidex®) or
tamoxifen during their participation in the ATAC (Arimidex®, Tamoxifen, Alone or in Combination) trial. Results
from LATTE will enable patients and their clinicians to make more informed decisions about the overall risks
and benefits of anastrozole and tamoxifen treatment.
Publications
During the reporting period, the ANZBCTG added a further 39 publications to its portfolio (see Publications
on page 91). Eight of these publications are summarised below.
ATAC (Arimidex®, Tamoxifen, Alone or in Combination) 10-year follow-up.
The ATAC study is one of the world’s largest and longest running breast cancer trials in postmenopausal
women with hormone-sensitive early breast cancer.
The trial opened in Australia and New Zealand in 1998 and international recruitment was completed in May
2000. More than 9,000 women from 381 centres participated worldwide including 174 women from 10
ANZBCTG participating institutions.
The current analysis, which reported on 10-year follow-up data, showed that for postmenopausal women
with hormone-sensitive early breast cancer, anastrozole significantly reduced the risk of breast cancer
recurring and improved cancer free survival.
The reduction in risk means that anastrozole is the first aromatase inhibitor to demonstrate a ‘carry-over’
effect with the benefits of this drug continuing to be apparent long term for many years after the active
treatment period. While tamoxifen has also shown a carry-over benefit, the benefit was larger for anastrozole
for the entire 10-year follow-up period.
The current analysis also reviewed data on reported side effects to treatment and fracture rates. This
is important because low bone density after menopause increases the risk of fracture, and this may be
aggravated by hormone blocking treatments like anastrozole. While more fractures were reported during the
period of active treatment with anastrozole, in comparison to the group of women who received treatment
with tamoxifen, the rates were similar in the post treatment follow-up period. Fewer treatment-related, serious
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side effects were reported for anastrozole in comparison to tamoxifen during the treatment period, but were
similar in number during the post treatment period.
These results suggest that the benefit of anastrozole treatment is maintained longer term and provides more
support for the use of this drug as initial treatment for postmenopausal women with hormone-sensitive early
breast cancer. These results were published in the Lancet Oncology in 2010 (11(12):1135-1141).
The effectiveness of treatment with anastrozole for women with a high body
mass index.
After the menopause, most oestrogen is produced in body fat, so increased body fat in this age group can
result in higher oestrogen hormone levels which increases the risk of developing breast cancer. Obesity in
women who are diagnosed with breast cancer has been linked to an increased risk of breast cancer recurring
after treatment and increased mortality.
Body Mass Index (BMI) is a measure used to assess human body fat based on an individual’s weight and
height. The BMI of women who participated in the ATAC study was recorded before they started treatment
with either anastrozole or tamoxifen. The ATAC study was coordinated in Australia and New Zealand by the
ANZBCTG. The impact of BMI on the rate of breast cancer recurrence and the relative benefit of treatment
with anastrozole compared to tamoxifen is reported in this analysis.
This research confirmed previous findings which showed that women who are obese (determined by a high
BMI) at the time breast cancer is diagnosed are more likely to have a breast cancer recurrence.
It was proposed by the researchers that anastrozole may be more effective in preventing a recurrence in
women with a high BMI. However, the results suggest that aromatase inhibitors are relatively more effective in
preventing recurrence in non-obese postmenopausal women. A possible explanation is that high oestrogen
levels (resulting from high BMI) may lead to incomplete oestrogen suppression by anastrozole, possibly
indicating that the dose of anastrozole should be increased for obese women. The authors recommended
that further research is undertaken in this area. These results were published in the Journal of Clinical
Oncology in 2010 (28(21):3411-3415).
How does adjuvant endocrine therapy affect cognitive function in
postmenopausal women?
Some women complain of problems with memory and thinking during and after their breast cancer treatment
and this has been largely attributed to chemotherapy. However, oestrogen plays an important role in cognitive
function and the potential impact of anti-oestrogen therapies (such as tamoxifen or aromatase inhibitors such
as letrozole) has been under-researched.
The Breast International Group (BIG) 1-98 Cognitive Function Substudy is an international clinical trial
coordinated in Australia and New Zealand by the ANZBCTG. Internationally, the substudy involved 120
women, including 43 from Australia and New Zealand. All the women who took part in the BIG1-98 trial
were postmenopausal, had been diagnosed with hormone-sensitive breast cancer and received five years of
treatment with tamoxifen or letrozole.
This substudy examined differences in cognitive function through a series of computer based tests (evaluating
detection, identification and memory tasks) and participant self-completed questionnaires. Cognitive function
was assessed during the fifth year of treatment and at one year after completion of treatment.
Two analyses were conducted and it was found that women who received treatment with the drug letrozole
had better memory and thinking skills than those who received tamoxifen. The first analysis assessed the
results of the initial cognitive function tests during the fifth year of treatment and were published in The Breast
in 2010 (19(5):388-395). These results showed that women taking letrozole during year five had better overall
cognitive function than those taking tamoxifen. Statistically, the difference in the scores between the two
groups was small to moderate.
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The second analysis, published in Breast Cancer Research and Treatment in 2011 (126(1):221-226) assessed
the results from the second cognitive function tests performed a year after hormone treatment was completed.
These results indicated that there was a moderate improvement in cognitive function after women completed
their hormone treatment, with either letrozole or tamoxifen. This result suggests that if hormone treatment
affects cognition in postmenopausal women, the effect is at least partly reversible after treatment is completed.
The effect of tamoxifen and radiotherapy in women with locally excised Ductal
Carcinoma In Situ.
Between May 1990 and August 1998 a clinical trial which assessed treatment options for women diagnosed
with Ductal Carcinoma In Situ (DCIS) was coordinated by the ANZBCTG and Cancer Research UK. Treatment
options for DCIS in this clinical trial included surgery, radiotherapy and hormone therapy.
The 1,701 women, including 187 from the ANZBCTG, who participated in this clinical trial received surgery
to remove the DCIS and this was followed by radiotherapy, or tamoxifen, or both treatments, or no additional
treatment. The results of this study have been reported previously, the current analysis reports the results of
long term follow-up data and was published in The Lancet Oncology in 2011 (12(1):21-29).
The results confirm that radiotherapy treatment significantly reduced the risk of breast cancer recurring in the
same breast (both DCIS and invasive disease) and suggests that the effect is long lasting. The results also
provide evidence that treatment with tamoxifen is effective in reducing the risk of breast cancer recurring,
including DCIS in the same breast and invasive breast cancer in the opposite breast, in women who have
been previously diagnosed with DCIS.
Preventative therapy for breast cancer: a consensus statement.
In March 2010 a group of international breast cancer experts including Professor John Forbes, Director of
Research for the ANZBCTG, met to assess current research and to develop a statement to direct future
breast cancer prevention strategies in order to reduce the impact of this disease on the community.
A number of important, ongoing prevention studies were discussed and it was noted that the use of selective
oestrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) in the breast cancer prevention setting
are being investigated and the results are eagerly awaited. The potential for other drugs such as statins (used in
the control of cholesterol), insulin (specifically metformin), aspirin, other non-steroidal, anti-inflammatory drugs
(NSAIDs), COX-2 inhibitors and bisphosphonates to prevent breast cancer were reviewed. The importance of
lifestyle factors such as maintaining healthy weight and increasing levels of physical activity were also noted.
The expert group produced a report which recommended streamlining current processes and the
requirements of regulatory authorities, to achieve faster approval of drugs for the prevention of breast
cancer. It was also suggested that consideration could be given to long term patent protection for drug
manufacturers willing to undertake preventative therapy research.
The report highlighted the promising results being seen in the area of biomarkers, particularly mammographic
breast density, and suggested that more research is required. An important conclusion was, that while advances
have been made, “preventative therapy must be integrated into the wider strategies of risk reduction” to further
reduce the impact of breast cancer, particularly in developed countries where the incidence of breast cancer is
highest. This article was published online in The Lancet Oncology on 28 March, 2011.
Adjuvant chemotherapy plus goserelin improves disease-free survival for
premenopausal patients with node-negative breast cancer – long term results of
IBCSG VIII.
From 1990-1999, 1,063 women, including 228 from the ANZBCTG, took part in a clinical trial to determine
the long term efficacy of either hormone treatment or chemotherapy, or a combination of both treatments for
early breast cancer which had not spread to the lymph nodes (node-negative breast cancer). This clinical trial
included women who had not reached the menopause at the time their breast cancer was diagnosed.
14
Women in this clinical trial received either hormone blocking treatment (goserelin) for 24 months, or six cycles
of chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil (CMF)), or six cycles of chemotherapy
followed by 18 months of hormone blocking treatment (CMF followed by goserelin). While a prior study
analysis was reported in 2003, this analysis reviewed the data after women had been followed-up for
approximately 12 years.
The results showed that the combination of CMF followed by goserelin was more effective than either of these
treatments given alone in reducing breast cancer recurrence for women with hormone-sensitive, node-negative
breast cancer, particularly for those women who were younger than 40 years at the time their treatment
commenced. It was noted that ovarian function was suppressed for a longer duration in these patients.
The authors acknowledged that current chemotherapy regimens are different and therefore the results of
IBCSG VIII are not applicable to the current management of breast cancer patients; and that the regimens
tested did not include tamoxifen, which would now be accepted as a required component of treatment.
However, there are a number of important research questions which remain unanswered including: the role
of longer term ovarian function suppression for younger women; the impact of treatment options on patients’
quality of life; and that more treatment options for women whose breast tumours are not hormone-sensitive
need to be identified. Many of these questions are the focus of current clinical trials research.
The results of this research were published online in the Annals of Oncology on 16 February 2011.
First line chemotherapy for patients with HER2 gene-amplified metastatic breast
cancer – two highly active therapeutic regimens (BCIRG 007).
This analysis explored whether the addition of the drug carboplatin to standard treatment improved outcomes
for women diagnosed with a type of breast cancer which has a growth receptor called HER2 and had
spread to other organs (metastatic cancer). Internationally, 263 women were recruited to the Breast Cancer
International Research Group (BCIRG) 007 trial, with 23 women participating from the ANZBCTG. Women
received the current standard treatment, including trastuzumab and docetaxel, or the same treatment with
carboplatin added.
The data, published in the Journal of Clinical Oncology in 2011 (29(2):149-156), did not demonstrate a
difference in the effectiveness of the two treatment regimens. However, there were some differences in the
rates of side effects such as nausea, blood counts and nerve damage. It was concluded that both regimens
are acceptable treatment options for women with metastatic breast cancer that has the HER2 growth receptor.
Annual Scientific Meetings
The ANZBCTG held its Annual Scientific Meeting in July 2010 at Cockle Bay Wharf, Sydney. More than 120
researchers and specialists from throughout Australia and New Zealand attended. We are particularly grateful
to our international colleagues (listed below) and our local colleagues whose participation in this meeting was
of great benefit to all those in attendance:
■■
Dr Karen Gelmon, Department of Medical Oncology Vancouver Centre, USA
■■
Prof John Robertson, University of Nottingham, UK
The ANZBCTG partnered with the Clinical Oncological Society of Australia (COSA), the peak multidisciplinary
organisation for health professionals in clinical oncology, for the COSA 37th Annual Scientific Meeting held at
the Melbourne Convention and Exhibition Centre in November 2010. Breast cancer was one of the tumour
streams highlighted during this meeting, which brought together cancer experts to present the latest research
and developments in cancer control.
15
A number of international colleagues (listed below), and members of the ANZBCTG made important
contributions to the meeting which led to an exceptional COSA Breast Program:
■■
Dr Rowan Chlebowski, UCLA Medical Centre, California, USA
■■
Mr Mark Kissin, Royal Surrey Hospital, Guildford, UK
■■
Dr Monica Morrow, Memorial Sloan-Kettering Cancer Centre, New York, USA
■■
Dr Ann Partridge, Dana-Farber Cancer Institute, Harvard, Illinois, USA
■■
Prof Edith Perez, Mayo Clinic, Florida, USA
■■
Dr Mark Robson, Memorial Sloan-Kettering Cancer Centre, New York, USA
■■
Dr Christos Sotiriou, Jules Bordet Institute, Brussels
COSA Tom Reeve Oration Award
Professor John Forbes, the ANZBCTG Director of Research, received the Clinical Oncological Society of
Australia (COSA) Tom Reeve Oration Award for Outstanding Contributions to Cancer Care. This award
recognises a national leader and resident in Australia, who has made a significant contribution over a long
period towards cancer care through research, clinical leadership and/or community service. This prestigious
award was presented to Professor Forbes in Melbourne at the COSA Annual Scientific Meeting dinner held
in November 2010.
Professor John Forbes receives
the Tom Reeve Oration Award for
Outstanding Contributions to Cancer
Care, from Professor Bruce Mann,
COSA President.
Operational Processes
The hard work of members of the Scientific Advisory Committee (SAC) and its Subcommittees, together with
the staff of the Trials Coordination Department (TCD) has resulted in a high level of successful clinical trial
development and activation during the reporting period.
The SAC sets research priorities for the ANZBCTG. Each of the three SAC Subcommittees meet regularly
to develop new trial concepts and to encourage the participation of investigators in all aspects of the
ANZBCTG clinical trials research program. The development of local ANZBCTG trials is a key responsibility
of these committees.
New positions have been established and new staff appointed within the TCD during the reporting period
to further improve trial activation timelines and increase support for member investigators and their research
16
teams to coordinate trials. Clinical trials are complex and the average time required to design, approve and
activate a trial for participant enrolment has been estimated to take two years (1). This involves many prior
steps, from consideration of the scientific merit of a new concept to the development of a trial protocol,
data collection forms, procedure manuals and databases to the provision of drug and kits to collect tissue
samples. Confirming funding to support the trial is essential, and obtaining approvals from regulatory bodies
can be a challenging as well as a time consuming process.
Trial management systems have been improved to support more efficient online enrolment of clinical trial
participants using the ANZBCTG website. This has saved time for research teams at participating institutions,
and the number of patients screened and enrolled can be more easily tracked which assists the ANZBCTG
to manage trial drug availability and trial completion timelines. TCD staff also provided research teams with
training in online data entry processes for a large international trial, which has improved the accuracy and
timelines of trial data submission.
Further work has been done to develop strategies to improve clinical trial recruitment and new approaches to
inform and engage potentially eligible women in their communities were initiated. Clinical trials are promoted
by developing posters and brochures for community groups, clinics and GP rooms; freecall numbers are
provided in Australia and New Zealand to collect women’s contact details; media coverage has been
extended, TCD staff contact women who register their interest in participating and provide them with more
information and connect them to research staff at their local hospitals.
In February 2011, Dr Eugene Leong completed his term as ANZBCTG Clinical Fellow. The Fellow position
aims to provide educational, research and career development opportunities for young clinical researchers in
the field of breast cancer through participation in the development, implementation and conduct of the clinical
and translational components of trials conducted by the ANZBCTG. The position is funded by the Cancer
Institute NSW and we are indebted to Dr Leong for his contribution.
1. Nass SJ, Moses HL, Mendelsohn J, Editors; A National Cancer Clinical Trials System for the 21st Century [Internet].
Washington (DC): Institute of Medicine of the National Academies; 2010 April [cited 2011 March 31]. Available from:
http://www.iom.edu/~/media/Files/Report Files/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-CenturyReinvigorating-the-NCI-Cooperative/NCI Cancer Clinical Trials 2010 Report Brief.pdf
Discretionary Research Funding
During the reporting period the ANZBCTG provided opportunities for its members to apply for Discretionary
Research Funding. This funding is available for pilot research projects to support participation in the
ANZBCTG research program. The proposals must have prior Scientific Advisory Committee approval and
be either related to existing research studies or relevant to the overall research agenda of the ANZBCTG.
Funding for this initiative comes from public donations made to the Group, without which these important
projects could not be supported.
Dr Jacquie Chirgwin, Arthralgia management – An application was approved to support a pilot study
investigating the role of glucosamine in the management of letrozole-induced arthralgia.
Dr Jacquie Chirgwin, SOLE-EST substudy – An application was approved for funding to undertake the
SOLE trial SOLE-EST substudy which will investigate changes in oestrogen levels and grip strength in SOLE
trial participants.
Dr Vinod Ganju, SETUP – An application was approved for funding to undertake the SETUP trial substudy of
breast cancer stem cell markers.
Dr David Porter, Lymphoedema following biopsy – an application was approved for funding to support a
pilot investigation of lymphoedema following sentinel node biopsy for breast cancer.
17
Dr Chee Lee, Olaparib in breast cancer – An application was approved for funding to support a phase I
study of olaparib in combination with metronomic cyclophosphamide in patients with metastatic
BRCA-associated cancer, triple-negative breast cancer and serous ovarian cancer.
Discretionary Site Infrastructure Funding
During the reporting period the ANZBCTG provided opportunities for its members to apply for Discretionary
Site Infrastructure Funding to assist their institutions to open ANZBCTG clinical trials. Funding for this
initiative comes from public donations made to the Group, without which these essential requests could
not be supported.
St Vincent’s Hospital, Melbourne (VIC) – An application was approved for funding to assist with the
activation of the IBIS-II trial at Goulburn Valley Base Hospital, a satellite site of St Vincent’s Hospital, Melbourne.
Haematology & Oncology Clinics of Australia (HOCA) Brisbane (QLD) – An application was approved
for funding to assist with the activation of the ANZ 0802 (TRIO-CIRG 012) trial at the Wesley Medical Centre,
Wesley Hospital, which is part of the HOCA consortium.
18
Clinical Trials Open
for Patient Entry
Prevention Trials
Breast cancer is the most common cancer in women worldwide, rates are highest in developing countries
and the worldwide incidence is expected to increase. Preventative therapy for women with an increased risk
of breast cancer due to a strong family history and/or other risk factors may include treatment with drugs,
such as tamoxifen, or access to aromatase inhibitors in ongoing clinical trials. Women who are invited to
participate in prevention clinical trials have either never had a diagnosis of invasive breast cancer, or are long
term breast cancer survivors.
The first international breast cancer prevention trial, IBIS-I, began in 1992 and involved seven countries and
more than 7,000 women. Almost one third of these women were from Australia and New Zealand and joined
the trial through the ANZBCTG.
In 2002, the results from IBIS-I demonstrated that tamoxifen, a well-established therapy for the treatment of
breast cancer, can reduce the occurrence of hormone receptor-positive breast cancer by about 30% in pre
and postmenopausal women at increased risk of the disease.
The landmark results of the IBIS-I trial paved the way for the next generation of prevention trials. In particular,
the IBIS-II trial which builds on results from the original IBIS trial and evaluates whether anastrozole, which may
be a better tolerated drug than tamoxifen, can prevent the development of breast cancer in postmenopausal
women at high risk. The ANZBCTG is the third highest recruiter of women to IBIS-II in the world, and we will
continue recruiting to this trial until early 2012, when the accrual goal is expected to be achieved.
The ANZBCTG trial LATER, which investigates longer term treatment with letrozole, aims to improve
surveillance and reduce the high long term risk of recurrence for breast cancer survivors.
ANZ 02P2 / IBIS-II Prevention and IBIS-II DCIS
International multi-centre trials of anastrozole versus placebo in postmenopausal women at increased risk of
breast cancer and tamoxifen versus anastrozole in postmenopausal women with hormone-sensitive DCIS.
These international clinical trials test the potential of a once-a-day hormone treatment for five years in
postmenopausal women who are at increased risk of breast cancer. IBIS-II builds on results from the first
prevention study, IBIS-I, an international trial which showed that tamoxifen could prevent breast cancer in
some women at increased risk, but was associated with some side effects.
Oestrogen can stimulate the growth of breast cancer cells. Hormone treatment with tamoxifen or the
aromatase inhibitor anastrozole, may prevent breast cancer developing by blocking the effects of oestrogen.
An international clinical trial, called ATAC (Arimidex®, Tamoxifen, Alone or in Combination), showed that
anastrozole (Arimidex®) was effective for the treatment of breast cancer. It also showed that anastrozole was
better tolerated and more effective in preventing breast cancer recurrence than tamoxifen overall, thus making
it a suitable candidate for use in the prevention setting.
The IBIS-II Prevention trial evaluates whether anastrozole can prevent the development of breast cancer in
postmenopausal women at high risk of the disease. The trial includes a substudy to investigate the effects of
anastrozole on bone mineral density. The substudy reached its accrual target in 2010.
19
The IBIS-II DCIS trial compares anastrozole with tamoxifen in postmenopausal women who have recently
undergone surgery to remove a form of pre-invasive breast cancer called Ductal Carcinoma In Situ (DCIS).
The purpose of this study is to investigate which drug is most effective at preventing the breast cancer
returning or a new breast cancer developing. It will also show which drug is better tolerated.
Women who are postmenopausal, not taking hormone replacement therapy, aged 40-70 years and are
at increased risk of breast cancer, either because of a family history of breast cancer or because of other
defined risk factors, may consider taking part in IBIS-II. There must have been no previous diagnosis of breast
cancer, unless this was a particular form of breast cancer called DCIS.
The ANZBCTG has enrolled 633 women to the IBIS-II Prevention trial and 151 women to the IBIS-II DCIS trial
(31 March 2011). These trials are expected to reach their accrual targets at the end of 2011.
The IBIS-II trials are supported by a National Health and Medical Research Council (NHMRC) Project Grant
(2009-2013).
Lead International Group: Cancer Research UK (CRUK)
ANZBCTG Study Chair:
Prof John F Forbes (Calvary Mater Newcastle)
22 March 2006 (IBIS-II Prevention)
18 November 2005 (IBIS-II DCIS)
First ANZBCTG Participant Enrolled: Patient Population
Prevention:
Postmenopausal
High risk
40-70 years
DCIS:
Postmenopausal
Hormone-sensitive
DCIS (without mastectomy)
40-70 years
R
A
N
D
O
M
I
S
A
T
I
O
N
anastrozole 1 mg daily for 5 years
placebo daily for 5 years
tamoxifen 20 mg + anastrozole
anastrozole 1 mg + tamoxifen
IBIS-II Prevention Bone Subprotocol (1000 Women)
T-Scores
_ -1.0
T>
-2.5 < T < -1.0
-4.0 <_ T <_ -2.5
or 1-2 low trauma
vertebral fractures
Stratum 1:*
RANDOMISATION
Stratum 3:
risedronate**
Stratum 2:
risedronate**
vs placebo
* Women in all strata will be monitored with dual energy x-ray absorptiometry (DXA) scans
and vitamin D and calcium supplements will be recommended.
** Risedronate 35 mg po once per week.
20
ANZ 0501 Later adjuvant Aromatase inhibitor Therapy for postmenopausal
women with Endocrine-Responsive breast cancer (LATER)
A randomised trial of letrozole plus usual care versus usual care without letrozole to prevent new breast
cancer events in postmenopausal women who have completed a minimum of four years of adjuvant
endocrine therapy for early, hormone-responsive breast cancer more than one year previous, and who are
disease-free at trial entry.
Many women who were diagnosed with and received standard treatment for breast cancer several years ago
are concerned about their ongoing risk of breast cancer returning. Until now, the management of ongoing risk
has been linked to surveillance by annual clinical review and mammography.
The LATER trial addresses the important question of whether additional treatment with the aromatase inhibitor
letrozole, commenced much later, for example from five to 15 years after the initial diagnosis of breast cancer,
could reduce the risk of breast cancer returning in this large and high risk group of women.
LATER is a very high priority trial to both improve outcomes for women and gain a better understanding of the
biology of breast cancer. Women who may be interested in taking part in LATER may not be currently under
the care of an oncologist. For this reason the ANZBCTG has a freecall number (Australia 1800 039 634 and
New Zealand 0800 770 119) for women who would like to receive more information about the LATER trial.
The ANZBCTG has enrolled 168 women to the LATER trial (31 March 2011).
The LATER trial is supported by a NHMRC Project Grant (2008-2012).
Lead International Group: ANZBCTG
ANZBCTG Study Co-Chairs:
Prof Michael Green (Royal Melbourne Hospital)
First ANZBCTG Participant Enrolled:
16 May 2007
Patient Population
Postmenopausal
Stratification
Institution
ER and/or PgR+ early BC
AET minimum 4 years
_ 12
AET completed >
months*
Disease-free BC
AI:
SERM:
AET:
LET:
Node status: N+/N-/UNK
AET: SERM/AI/Other
R
A
N
D
O
M
I
S
A
T
I
O
N
LET + usual care
for 5 years
Usual care (without LET)
for 5 years
aromatase inhibitor
selective oestrogen receptor modulator
adjuvant endocrine therapy
letrozole 2.5 mg daily po
_ 5 years after diagnosis of primary breast cancer.
* Study entry will be >
21
Local and Systemic Therapy Trials
Breast cancer is treated both locally (surgery and/or radiotherapy) and, when required, also systemically with
drug therapy. Local treatments are used to remove, destroy or control breast cancer cells in a specific area,
and systemic treatments are used to destroy or control breast cancer cells which may have spread from the
breast to other parts of the body through the lymphatic system and blood vessels.
Using appropriate local and systemic treatments reduces the risk of breast cancer recurrence, improves
prognoses and saves lives. Over the last ten years many improvements in local and systemic treatment
options have been delivered by clinical trials research and more breast cancer patients are able to have
treatments tailored to their specific type of disease. Sentinel node biopsy, now a standard of care for early
breast cancer, is associated with fewer side effects and enables many patients to avoid more extensive
surgery. Treatment with aromatase inhibitors for hormone-sensitive breast cancer, the addition of taxanes to
chemotherapy regimens, and trastuzumab for HER2-positive breast cancer, are examples of some of the
advances that have been achieved.
Many people, however, will still experience a recurrence of breast cancer and continued research into new,
more effective treatment combinations and targeted therapies is essential. It is not always clear why some
people respond differently to treatments and have different outcomes. Current systemic therapy trials aim
to refine drug treatments in particular subgroups of women who remain at higher risk of recurrence despite
standard systemic treatments.
IBCSG 22-00
Low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients
with ER-negative and PgR-negative breast cancer.
Several chemotherapy drugs have been shown to reduce the formation of new blood vessels (angiogenesis)
and stop tumour cells from growing quickly or spreading to different parts of the body. However, it is not yet
known which drug combination or duration is the most effective option following surgery for breast cancer.
Using lower doses of chemotherapy drugs for a longer period may be more effective, participants may
experience fewer side effects, and there may be an increased benefit due to the longer treatment time.
This study will determine if low-dose chemotherapy with oral cyclophosphamide and methotrexate, given
for 12 months following three to six months of standard chemotherapy, delays breast cancer recurrence
more effectively than short term standard chemotherapy alone for women with breast cancer that is not
hormone-responsive.
In IBCSG 22-00, participants are randomised to one of two groups. One group receives chemotherapy
drugs every three to four weeks, for up to six cycles. The other group receives the same treatment as the
first group, followed by low-dose chemotherapy in tablet form, taken one or two times per day, twice a week
for one year.
The ANZBCTG has enrolled 74 of the 951 women participating in this trial internationally (31 March 2011).
Lead International Group: International Breast Cancer Study Group (IBCSG)
22
12 August 2003
Stratification
S
U
R
G
E
R
Institution
Menopausal status
(pre vs post)
Induction chemotherapy
(AC/EC x 4 vs other regimens)
Y
R
A
N
D
O
M
I
S
A
T
I
O
N
Before
induction
chemotherapy
begins or any
time prior to
day 56** of the
last cycle of
induction
* Approved induction chemotherapy regimens
C: cyclophosphamide 50 mg/day orally
M: methotrexate
2.5 mg/twice a day orally
A
induction
chemotherapy*
B
induction
chemotherapy*
followed by
CM x 12 months
continuously for 1 year (365 days)
days 1 and 2 of every week for 1 year (52 weeks)
** Amendment 3: November 2005 - extended the timing of randomisation
IBCSG 24-02 / BIG 2-02 Suppression of Ovarian Function Trial (SOFT)
A phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant
therapies for premenopausal women with endocrine-responsive breast cancer.
SOFT completed recruitment in Australia and New Zealand in June 2010. Participants from Europe continued
to be enrolled in SOFT until January 2011 to complete recruitment for a substudy which was not opened by
the ANZBCTG. The ANZBCTG enrolled 240 of the 3,066 women participating in SOFT internationally.
Young, premenopausal women with breast cancer may have a poorer long term prognosis despite receiving
chemotherapy. The hormone oestrogen, which is produced by the ovaries, can encourage the growth of
cancer cells in patients with hormone-responsive breast cancer. If normal ovarian activity is stopped (ovarian
function suppression), the production and action of oestrogen is decreased and hormone-responsive breast
cancers cannot grow as quickly.
Chemotherapy, hormone treatments (such as tamoxifen or an aromatase inhibitor) and stopping ovarian
activity (by using the drug triptorelin, surgery, or radiation therapy) may all reduce the risk of breast cancer
returning in young women with hormone-responsive breast cancer. However, it is unclear how best to
combine these treatments or whether all three are necessary.
SOFT is for young, premenopausal women with hormone-responsive breast cancer, who in many cases will
have received adjuvant chemotherapy prior to study entry and who still have functioning ovaries. This trial will
determine if exemestane or tamoxifen is the better hormone treatment for these women, and also whether
turning off ovarian activity for five years further reduces relapse rates.
SOFT is supported by a NHMRC Project Grant (2008-2010).
Lead International Group:
International Breast Cancer Study Group (IBCSG)
Dr Prue Francis (Peter MacCallum Cancer Centre)
23
ANZ 0701 (Co-SOFT)
A substudy to the SOFT trial which evaluates the cognitive function of premenopausal women with
endocrine-responsive breast cancer participating in SOFT.
Co-SOFT completed recruitment in Australia and New Zealand in April 2010 and internationally in December
2010. The ANZBCTG enrolled 19 of the 83 women participating in this trial internationally.
Potentially curative treatment for breast cancer might, in some women, have an adverse effect on their
subsequent cognitive function. It is known that oestrogen has an important role in brain function. Evidence
from small studies of women with conditions other than breast cancer, suggests that suppressing ovarian
function in premenopausal women may adversely affect cognition. Similarly, standard treatments for
hormone-responsive breast cancer (such as tamoxifen and aromatase inhibitors) work by interfering with the
action of oestrogen and therefore, may have an effect on brain functions such as memory and thinking.
The international Co-SOFT substudy, which was developed by the ANZBCTG, uses computerised card
memory games and questionnaires to monitor changes in brain function before, and after one year of breast
cancer treatment for patients taking part in SOFT.
The Co-SOFT substudy is supported by a NHMRC Project Grant (2007-2011).
Assoc Prof Kelly-Anne Phillips
(Peter MacCallum Cancer Centre)
S
U
R
G
E
R
Y
Patient Population
Stratification
Premenopausal women
with histologically proven
hormone receptor-positive
breast cancer
Institution
_ 10% and/or PgR >
_ 10%
ER >
Number of positive nodes
(0;1 or more)
No CT stratum
(randomise after surgery)*
CT stratum (randomise within
8 months after completing
chemotherapy)*
Prior CT
(Y/N)
Intended method of OFS
(GnRH analogue for
5 years; surgical
oophorectomy; ovarian
irradiation)
*
R
A
N
D
O
M
I
S
A
T
I
O
N
TAM x 5 yrs
OFS + TAM x 5 yrs
OFS + EXE x 5 yrs
Years
0 1
Cognitive Function Assessments
_ 2 months duration if anthracycline included;
CT:
chemotherapy >
>
_ 4 months duration if no anthracycline is included
TAM: tamoxifen
20 mg daily po for 5 years
EXE: exemestane
25 mg daily po for 5 years
OFS: ovarian function suppression - triptorelin: 3.75 mg injection every 28 days for 5 years
or surgical oophorectomy or ovarian irradiation
* Participants may have received tamoxifen or an aromatase inhibitor prior to randomisation.
Participants must remain premenopausal after chemotherapy.
24
IBCSG 25-02 / BIG 3-02 Tamoxifen and EXemestane Trial (TEXT)
A phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for
premenopausal women with endocrine-responsive breast cancer.
TEXT completed recruitment in Australia and New Zealand in March 2011. The ANZBCTG enrolled 249 of the
2,672 women participating in this trial internationally.
This trial compares tamoxifen with the aromatase inhibitor exemestane, in women who also have ovarian
function suppression using the drug triptorelin. Women receive triptorelin plus tamoxifen or triptorelin plus
exemestane. Tamoxifen and exemestane are two different types of drugs which limit the effects of oestrogen
on cancer cell growth. Tamoxifen works by stopping oestrogen from fuelling cancer cells, while exemestane
works by preventing the production of oestrogen.
Research has shown that exemestane works better in postmenopausal women because their ovaries are no
longer producing oestrogen. TEXT will determine if suppressing ovarian function in premenopausal women (ie
reducing oestrogen production) will allow exemestane to work in the same way as it does for postmenopausal
women. This trial is designed for participants who should receive ovarian function suppression from the start
of their adjuvant breast cancer treatment.
TEXT is supported by a NHMRC Project Grant (2008-2010).
The effect of hormone therapy on bone health is not fully understood. A substudy, called TEXT-Bone, will
assess the bone health of participants in TEXT at selected ANZBCTG centres. This substudy will measure
bone density and analyse blood samples collected prior to, during and after treatment on TEXT, and assess
changes over this time. Women who are taking part in TEXT may enrol in TEXT-Bone until the accrual target
of this substudy has been achieved.
The ANZBCTG has enrolled nine of the 61 women contributing additional data for TEXT-Bone internationally
(31 March 2011).
ANZBCTG Study Chair: Dr Prue Francis (Peter MacCallum Cancer Centre)
S
U
R
G
E
R
Y
Patient Population
Stratification
Premenopausal women
with histologically proven
hormone receptor-positive
breast cancer
Institution
_ 10% and/or
ER >
_ 10%
PgR >
Candidates to begin
GnRH analogue from the
start of adjuvant therapy
CT:
chemotherapy
TAM: tamoxifen
EXE: exemestane
Triptorelin
CT (Y/N)
Number of positive nodes
(0; 1 or more)
*
R
A
N
D
O
M
I
S
A
T
I
O
N
Triptorelin x 5 yrs
+ TAM x 5 yrs
_ CT )
(+
Triptorelin x 5 yrs
+ EXE x 5 yrs
_ CT )
(+
if used, should begin at the same time as Triptorelin.
>
_ 2 months duration if anthracycline is included;
>
_ 4 months if no anthracycline is included
20 mg daily po for 5 years**
25 mg daily po for 5 years**
3.75 mg IM injection every 28 days for 5 years, to begin from the start of the adjuvant therapy.
* Randomisation prior to receiving any adjuvant systemic therapy.
** Tamoxifen or exemestane should start after adjuvant chemotherapy has been completed or at least 6-8 weeks after the initiation of triptorelin, whichever is later.
25
IBCSG 34-05 / SWOG S0230 Prevention Of Early Menopause Study (POEMS)
A phase III trial of LHRH analogue administration during chemotherapy to reduce ovarian failure following
standard adjuvant chemotherapy in early stage, hormone receptor-negative breast cancer.
One in four breast cancer patients are premenopausal and chemotherapy treatment is usually given to these
patients to destroy any remaining cancer cells after surgery, and to prevent these cells from growing and
spreading to other parts of the body. Unfortunately the most common long term side effect of this treatment
is early menopause. In addition to avoiding the potential long term medical problems resulting from early
menopause (such as osteoporosis and heart disease), many young women also wish to avoid infertility
resulting from treatment.
The international trial POEMS is evaluating whether the LHRH analogue goserelin, which temporarily
suppresses ovarian function, can prevent permanent ovarian failure after chemotherapy in premenopausal
women with hormone receptor-negative breast cancer.
In the POEMS trial, premenopausal women with breast cancer receive standard chemotherapy with or
without goserelin. Menopausal symptoms are monitored and menopausal status is assessed by menstrual
reporting and blood tests during the study.
If goserelin proves to be effective, this will be a major step forward in reducing one of the most significant long
term side effects of chemotherapy for premenopausal women with breast cancer.
Lead International Group: The Southwest Oncology Group (SWOG) and International Breast Cancer Study Group (IBCSG)
ANZBCTG Study Chair: Assoc Prof Kelly-Anne Phillips
29 September 2006
Patient Population
Age: < 40 vs 40-49
Stage I, II or IIIA
breast cancer
(neo)adjuvant
chemotherapy regimen:
anthracycline based vs
non-anthracycline
based
Radiotherapy:
Goserelin:
26
Stratification
Premenopausal
>
_ 18 < 50 years
ER- and PR-
R
A
N
D
O
M
I
S
A
T
I
O
N
Arm 1
standard (neo)adjuvant
chemotherapy
containing
cyclophosphamide
Arm 2
goserelin + standard
(neo)adjuvant
chemotherapy
containing
cyclophosphamide
radiation therapy may be given to breast/chest wall/lymph node groups while on protocol treatment at clinician's discretion.
3.6 mg sc every 4 weeks - begins one week prior to first chemotherapy treatment and continues until the last chemotherapy treatment.
IBCSG 35-07 / BIG 1-07 Study Of Letrozole Extension (SOLE)
A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following four to six
years of prior adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive,
node-positive early stage breast cancer.
After initial treatment for hormone-responsive breast cancer, standard long term treatment usually includes at least
five years of hormone treatment. For postmenopausal women, this hormone treatment usually consists of tamoxifen
or an aromatase inhibitor such as letrozole. However, half of all the recurrences in these women occur between
five and 15 years after their initial diagnosis, when the five years of hormone treatment has been completed.
Research has shown that extending hormone treatment beyond the usual five years may prevent or delay breast
cancer recurrence and may prolong survival, but the best treatment plan and length of treatment is still unclear. In
addition, results from laboratory studies indicate that short breaks from letrozole treatment may make letrozoleresistant breast cancer cells more vulnerable to letrozole treatment when the treatment is restarted. Scheduling
treatment breaks from letrozole may therefore provide further improvement in breast cancer outcomes.
The international trial SOLE, is evaluating whether having three-month treatment breaks once a year, during
five years of extended letrozole treatment, will further prevent or delay breast cancer from returning.
The effects of hormonal therapy on oestradiol levels and the link between changing oestradiol levels and
treatment side effects and quality of life is not well known. An additional substudy of the SOLE trial, called
SOLE-EST, will assess the effect hormonal therapy has on oestradiol levels and the possible correlation of
these changes on quality of life and treatment side effects, in selected patients participating in SOLE.
Women interested in taking part in SOLE may not currently be under the care of an oncologist. For this
reason the ANZBCTG has a freecall number (Australia 1800 709 671 and New Zealand 0800 804 591) for
enquiries from interested women.
The ANZBCTG has enrolled 177 of the 2,376 women participating in this trial internationally (31 March 2011).
ANZBCTG Study Chair: Dr Jacquie Chirgwin (Box Hill and Maroondah Hospitals)
Patient Population
Stratification
Postmenopausal
Institution
ER and/or PgR+
early BC
Prior AET
(AI(s) SERM(s)):
AI alone, SERM
alone, both
SERM and AI
4-6 years of prior
AET therapy
Node-positive at
initial diagnosis
19 February 2009
*
R
A
N
D
O
M
I
S
A
T
I
O
N
LET continuously x 5 yrs
Intermittent LET
9m
0
9m
12
9m
24
9m
36
12 m
48
60
* Within 12 months of the last dose of prior endocrine therapy
AET:
LET:
Intermittent LET:
adjuvant endocrine therapy
letrozole 2.5 mg daily po for 5 years of adjuvant therapy
2.5 mg daily po for the first 9 months of years 1 through 4, followed by 12 months
in year 5
Patients must have had proper local treatment including surgery with or without radiotherapy for primary
breast cancer with no known clinical residual loco-regional disease.
27
ANZ 0702 / BIG 2-06 / N063D / EGF106708 Adjuvant Lapatinib and/or
Trastuzumab Treatment Optimisation study (ALTTO)
A randomised, multi-centre, open-label phase III study of adjuvant lapatinib, trastuzumab, their sequence and
their combination, in patients with HER2/ErbB2-positive primary breast cancer.
ALTTO completed recruitment in Australia and New Zealand in July 2010. The ANZBCTG enrolled 222 of the
8,283 women participating in this trial internationally (31 March 2011). Enrolment of participants from North
America continues, the international recruitment target is expected to be achieved by July 2011.
Many breast cancer cells have growth receptor molecules on their surface. Growth receptors are similar to
antennae which protrude from the cell and allow specific molecules to attach to the cell and influence the
cell’s growth. One particular type of growth receptor is known as HER2. Patients with this type of breast
cancer have a greater risk of the cancer returning after their initial treatment.
The current standard treatment for HER2-positive breast cancer is the drug trastuzumab which is given in
combination with other adjuvant treatments. However, some women still experience a recurrence of their
disease, and others are unable to tolerate therapy due to side effects. HER2 targeted therapies which work
differently, and have different side effect profiles, are under development in order to address these issues.
Lapatinib is a new HER2 blocking drug which has been shown to slow or stop the growth of HER2-positive
breast cancer which has spread to other parts of the body (advanced breast cancer). Lapatinib has also been
effective when trastuzumab has not worked and in treating breast cancer that has spread to the brain. It is a
tablet based therapy, in contrast to trastuzumab which is given intravenously.
The ALTTO trial will extend our knowledge of optimal HER2 therapy in women with HER2-positive breast
cancer, by comparing treatment with trastuzumab alone to lapatinib alone, or combinations of trastuzumab
with lapatinib. All participants will receive treatment for 12 months. Some participants may also receive
chemotherapy with a taxane for the first 12 weeks of treatment if their oncologist thinks this is indicated.
In this study, participants may also donate a blood sample which will help researchers to better understand
why some groups of people have a different response to a medication, possibly due to genetic differences.
28
Lead International Group: Breast International Group (BIG)
ANZBCTG Study Chair: Assoc Prof Fran Boyle (Mater Sydney)
ANZBCTG Study Co-Chair: Dr Marion Kuper-Hommel (Waikato Hospital, NZ)
Patient
Population
S
U
R
G
E
R
Y
Stratification
Completely
excised HER2positive invasive CT timing
breast cancer
ER and/or PgR
positive vs
(Neo)adjuvant
negative
anthracyclinebased
Lymph nodes
chemotherapy
not assessed
completed
(neoadjuvant
Hormone
receptor status
known
chemotherapy)
vs 1-3 positive
_ 4 positive
vs >
Design 1**
CT
completed
Design 2**
concurrent
paclitaxel
or
docetaxel
(12 weeks)
R
A
N
D
O
M
I
S
A
T
I
O
N
trastuzumab x 52 weeks
lapatinib x 52 weeks
trastuzumab
x 12 weeks
wash out
x6
weeks
lapatinib
x 34
weeks
lapatinib + trastuzumab x 52 weeks
Total treatment
duration: 52 weeks
Design 1: all CT completed
prior to randomisation
Design 2: concurrent paclitaxel 80 mg/m²
IV weekly (12 weeks) or docetaxel 75 mg/m²
IV every 3 weeks (12 weeks)
Trastuzumab only
6 mg/kg IV* every 3 weeks
trastuzumab 2 mg/kg IV† weekly for 12
weeks, then 6 mg/kg IV every 3 weeks for
40 weeks
Lapatinib only
1500 mg po daily
750 mg po daily for 12 weeks#, then
1500 mg po daily for 40 weeks
Sequential
trastuzumab 2 mg/kg IV†
weekly for 12 weeks → 6 week
washout → lapatinib 1500 mg
po daily for 34 weeks
trastuzumab 2 mg/kg IV† weekly for 12 weeks
→ 6 week washout → lapatinib 1500 mg po
daily for 34 weeks
Combination
lapatinib 1000 mg po daily +
trastuzumab 6 mg/kg IV* every
3 weeks
lapatinib 750 mg po daily + trastuzumab
2 mg/kg IV† weekly for 12 weeks#, then
lapatinib 1000 mg po daily + trastuzumab
6 mg/kg IV every 3 weeks for 40 weeks
* 8 mg/kg IV loading dose
†
4 mg/kg IV loading dose
#
Use of prophylactic G-CSF is mandatory for administration of docetaxel concomitant with lapatinib (with or without trastuzumab).
Treatment to commence within 14 days of randomisation.
Radiotherapy permitted concomitantly with biologic therapy in all treatment arms (both designs), if indicated.
** Design 1 (no concurrent taxane) closed to screening on 15 March 2009
Design 2 (concurrent taxane) closed to screening on 31 March 2010
29
ANZ 0901 / PACCT-1 Trial Assigning IndividuaLized Options for Treatment (TAILORx)
A phase III, multicentre, multinational, randomised trial of adjuvant chemotherapy plus hormone treatment
versus adjuvant hormone treatment alone for patients with previously resected, axillary node-negative,
invasive breast cancer with various levels of risk for recurrence.
TAILORx completed recruitment in October 2010, with a total international enrolment of 10,264 women. The
ANZBCTG commenced recruiting to this study six months before the international recruitment target was
achieved, within this short period 25 women were enrolled from Australia and New Zealand.
Many patients who are diagnosed with hormone-responsive breast cancer are adequately treated with
hormone treatment alone and may not benefit from the addition of chemotherapy, thereby avoiding the side
effects associated with this treatment. The decision to include chemotherapy as part of a patient’s treatment
is largely based on those characteristics of the tumour pathology and size, which are generally associated
with an unfavourable prognosis. What is needed is a test which more accurately predicts which individuals
are likely to benefit from chemotherapy and which individuals are not.
Gene expression profiling research has resulted in the identification of 21 breast cancer related genes which
collectively have been shown to identify groups of patients who may, or may not, benefit from the addition of
chemotherapy. The 21 gene test, known as the Oncotype DX® Assay, tests the tumour tissue taken at the time
of surgery and returns a risk score rating in either the low, intermediate or high risk range. A patient whose
tumour returns a score in the low risk range can receive hormone treatment alone. A patient whose tumour
returns a score in the high risk range is more likely to benefit from receiving chemotherapy and hormone
treatment. For a patient whose tumour returns a score in the intermediate risk range, it is not clear if hormone
treatment should be given alone or with chemotherapy. The international trial TAILORx is evaluating this question.
Participants whose tumours return an intermediate risk score will be randomised to receive either hormone
treatment alone or chemotherapy with hormone treatment.
Lead International Group: Eastern Cooperative Oncology Group (ECOG)
Assoc Prof Joanna Dewar (Sir Charles Gairdner Hospital)
ANZBCTG Study Co-Chairs: Patient
Population
ER+ and/or PR+
Node-negative
Candidate for
adjuvant CT
in addition
to hormonal
therapy
RS:
CT:
RT:
QoL: 30
P
R
E
R
E
G
I
S
T
R
A
T
I
O
N
Oncotype
DX® Assay
R
E
G
I
S
T
R
A
T
I
O
N
Arm A
hormonal
therapy
Secondary
Study
Group-1
RS < 11
Registered
Stratification
Primary
Study Group
RS 11-25
Randomised
Secondary
Study
Group-2
RS > 25
Registered
Tumour Size:
<
_ 2.0 cm vs >
_ 2.1 cm
Post- vs Pre- or Perimenopausal
Planned CT
Planned RT
Oncotype DX® RS
(11-15, 16-20,
21-25)
R
A
N
D
O
M
I
S
A
T
I
O
N
Arm B
hormonal
therapy
Arm C
CT +
hormonal
therapy
Arm D
CT +
hormonal
therapy
Recurrence Score
Chemotherapy: taxane-containing (paclitaxel, docetaxel) vs non-taxane-containing
Radiation Therapy (whole breast, no boost planned vs whole breast, boost planned vs partial breast irradiation planned vs no planned radiation therapy (for patients who have had a mastectomy))
Quality of Life assessments performed for Arms A, B, C, D
ANZ 0802 / TRIO-CIRG 012
A multicentre, multinational, randomised, double blind phase III study of IMC-1121B plus docetaxel versus
placebo plus docetaxel in previously untreated patients with HER2-negative, unresectable, locally recurrent or
metastatic breast cancer.
Breast cancer is the most common cancer in women. Although treatments for breast cancer have improved
significantly, for approximately three in 10 patients the cancer will return at some point after initial treatment.
If the cancer has spread from the original site to other organs or tissues this is known as metastatic breast
cancer. Available treatments are not always successful in controlling the spread of metastatic disease and the
chance of cure is unlikely. Further treatment options are needed for these patients.
Anti-angiogenic agents are a new class of drug which are able to starve the cancer cells by preventing the
growth of new blood vessels. This results in cell death and subsequent shrinkage of the cancer. These drugs
have been used in treating other types of cancer and their efficacy is now being explored in breast cancer.
This trial aims to investigate how effective and safe one of these new experimental drugs Ramucirumab®
(IMC-1121B) is in treating HER2-negative metastatic breast cancer when combined with a standard
chemotherapy drug, docetaxel (Taxotere®). Tumour tissue samples will be collected to help researchers
understand why some trial participants may be more sensitive to the trial treatments than others. Participants
may also donate blood samples which will help researchers to better understand why some groups of people
have a different response to a medication, possibly due to genetic differences.
This trial is expected to achieve the required recruitment of 1,113 participants in December 2011.
Lead International Group: Cancer International Research Group (CIRG)
ANZBCTG Study Chair: Assoc Prof Nicole McCarthy (Royal Brisbane and Women’s Hospital and Wesley Medical Centre)
10 September 2010
Patient
Population
>
_ 18 years
Metastatic or
locally-recurrent
and inoperable
with curative
intent, measurable
and/or nonmeasurable
lesions.
No previous
chemotherapy
for metastatic or
locally recurrent,
inoperable breast
cancer.
Stratification
Geographical
region
Prior
(neo)adjuvant
taxane therapy
(yes/no)
Visceral
metastasis
(yes/no)
Hormone
receptor status
(positive vs
negative/
unknown)
Ratio
R
A
N
D
O
M
I
S
A
T
I
O
N
2/3
Docetaxal +
IMC-1121B
*
PD
or
1/3
UT
Docetaxal +
Placebo
or
F/UP
for at least
3 years
after
discontinuation
of study
therapy
CW
Docetaxal:75 mg/m2 iv q3wks
IMC-1121B:
10 mg/kg iv q3wks
Placebo:
10 mg/kg iv q3wks
* Treatment will continue until progressive disease (PD), unacceptable toxicity (UT), or participant's consent is withdrawn (CW).
31
ANZ 1001 Study of Oestrogen Receptor Beta and Efficacy of Tamoxifen (SORBET)
A single arm phase II study of the efficacy of tamoxifen in triple negative (oestrogen receptor alpha negative,
progesterone receptor negative, HER-2 negative) but oestrogen receptor beta positive metastatic breast cancer.
About 15% of breast cancers diagnosed are a type which is called ‘triple-negative’. These cancers are more
resistant to treatment because they lack the three most common treatment targets known as receptors.
Women diagnosed with triple-negative breast cancer usually have a poorer prognosis as their disease is more
likely to spread to other sites in the body.
Currently these women are treated with standard chemotherapy which can have benefits but which is also
associated with significant side effects often compromising their quality of life.
Tamoxifen is a longstanding and successful hormone treatment for women with hormone-sensitive breast cancer,
specifically oestrogen receptor (ER) and/or progesterone receptor (PR) positive breast cancer. There are two
different forms of the oestrogen receptor, oestrogen receptor alpha (ERα) and oestrogen receptor beta (ERβ).
Researchers have measured ERβ in stored tissue from women who received treatment with tamoxifen. It was
found that the women who had breast cancers that were ERα-negative, but ERβ-positive had longer survival
times than those with tumours that were negative for both receptors. This led to the hypothesis for SORBET, that
tamoxifen may be an effective treatment for women with triple-negative breast cancers that are ERβ-positive.
At least 20% of triple-negative breast cancers are ERβ-positive. It is hoped that SORBET will show that
daily treatment with tamoxifen, a low cost and well tolerated drug, can control the growth and spread of
triple-negative, ERβ-positive metastatic breast cancer. If this is so, tamoxifen will be added to the treatment
options, which currently focus on chemotherapy, for these women. It may also lead to the investigation of
tamoxifen as treatment for triple-negative, ERβ-positive early breast cancer. Results of this research will have
implications worldwide in the treatment and management of women with this type of breast cancer.
The ANZBCTG has enrolled one of the 66 women who will participate from 12 institutions throughout
Australia and New Zealand (31 March 2011).
The SORBET trial is supported by ANZBCTG Discretionary Funding.
ANZBCTG Study Co-Chairs:
Dr Belinda Kiely (Macarthur Cancer Therapy Centre)
First ANZBCTG Participant Enrolled: 14 March 2011
Patient Population
Triple negative BC
Metastatic disease
amenable to biopsy
Chemotherapy
currently not indicated
At least one
measurable lesion
*
**
32
S
C
R
E
E
N
I
N
G
*Confirmed
ER beta positive;
but ER alpha
and PgR absent
R
E
G
I
S
T
R
A
T
I
O
N
Tamoxifen
20 mg daily
**PD or UT or CW
Diagnostic metastatic tissue (FFPE block of 5 unstained slides) must be centrally confirmed
ER beta positive.
Tamoxifen 20 mg daily will continue until progressive disease (PD), unacceptable toxicity (UT),
or withdrawal of participant's consent (CW).
ANZ 1002 Post-operative Radiotherapy Omission in Selected Patients with Early
breast Cancer Trial (PROSPECT)
A single arm phase II study using magnetic resonance imaging (MRI) to select patients with early breast
cancer for omission of post-operative radiotherapy.
For women diagnosed with early invasive breast cancer, after breast conserving surgery their standard
treatment includes radiotherapy given to the affected breast to reduce the risk of breast cancer returning
to that breast (local recurrence). Modern breast cancer treatment is very effective, the majority of women
having no recurrence of their disease after treatment. The need for radiotherapy depends on the risk of local
recurrence occurring after surgery alone. If the chance is minimal, there may be no need for radiotherapy.
Radiotherapy treatment is usually given as a daily dose over five weeks, and receiving radiotherapy treatment
can lead to some short and longer term side effects. These can include fatigue, skin redness and discomfort,
and in the longer term, side effects may include discomfort in the breast, thickening of breast tissue, and very
occasionally more serious problems.
PROSPECT is a pilot clinical trial which will use a new technology, breast magnetic resonance imaging (MRI),
in combination with review of pathological features of the breast tumour to prospectively identify women
who can safely avoid radiotherapy because their risk of local recurrence is very low. PROSPECT will examine
whether the abnormalities that can be detected by breast MRI contribute to the likelihood of local recurrence,
and hence the need for post-surgery radiotherapy treatment. Samples of tumour tissue will be collected to
further our knowledge about breast cancer.
If it is found that radiotherapy can be omitted without compromising local recurrence, it could significantly
alter the management of women with early breast cancer as well as decrease costs to the health care
system. There are benefits of safely foregoing radiotherapy for women with a low risk of breast cancer
recurrence which are particularly significant for rural and remote women, who frequently choose total
mastectomy (breast removal) to avoid the need to have a treatment that requires them to be absent from
home for a prolonged period.
The PROSPECT clinical trial is now open at the Royal Melbourne Hospital, Victoria. If this phase II trial
demonstrates an acceptably low rate of local recurrence, a larger, multicentre randomised clinical trial will be
conducted in ANZBCTG institutions throughout Australia and New Zealand.
The PROSPECT trial is supported by ANZBCTG Discretionary Funding.
ANZBCTG Study Chair: Prof Bruce Mann (Royal Melbourne Hospital)
Pending
Patient Population
_ 50
Female, aged >
Histologically confirmed invasive,
_ 20 mm
unifocal, unilateral breast cancer <
pN0 or pN1 (mi) by sentinel node biopsy
or axillary dissection
_ 2mm margins (invasive and DCIS)
WLE >
Pre-op MRI*
R
E
G
I
S
T
R
A
T
I
O
N
standard treatment
without
radiotherapy
WLE: wide local excision
MRI: magnetic resonance imaging
* nil/minimal, mild parenchymal enchancement only
33
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34
Clinical Trials Completed
Prevention Trials
Opened by the
ANZBCTG
Participant accrual
completed
ANZ 9002 / Ductal Carcinoma In Situ (DCIS): A study to
compare the efficacy of additional tamoxifen, or radiotherapy
to the breast, or both treatments, with no additional treatment
following complete surgical excision of ductal carcinoma in situ
of the breast.
September 1991
December 1998
ANZ 92P1 / IBIS-I: A study to determine whether tamoxifen is
effective in reducing the incidence of breast cancer in women
at high risk of developing breast cancer. This is a prospective
double-blind placebo controlled trial.
April 1992
March 2001
Pre-operative Systemic Therapy Trials
Opened by the
ANZBCTG
Participant accrual
completed
ANZ 0301 / BCIRG 103: A phase II, presurgical study to
evaluate molecular alterations that occur in human breast
cancer tissue and normal skin after short term exposure to
ZD1839 (IRESSA™) and to correlate these alterations with
pharmacokinetic parameters.
May 2003
December 2004
ANZ 0502 (NeoGem): A phase II trial evaluating the efficacy
and safety of epirubicin and cyclophosphamide (EC) followed
by docetaxel with gemcitabine (DG) (+ trastuzumab if
HER2-positive) as neoadjuvant chemotherapy for women with
large operable or locally advanced breast carcinoma.
April 2006
July 2009
35
Surgical Trials
Opened by the
ANZBCTG
Participant accrual
completed
IBCSG 10-93: Surgical therapy with or without axillary node
clearance for breast cancer in the elderly who receive adjuvant
therapy with tamoxifen.
May 1993
December 2002
IBCSG 21-99 / NCCTG N9431: Menstrual Cycle and Surgical
Treatment of Breast Cancer.
November 1999
December 2001
IBCSG 23-01: A randomised trial of axillary dissection versus
no axillary dissection for patients with clinically node-negative
breast cancer and micrometastases in the sentinel node.
June 2005
February 2010
Opened by the
ANZBCTG
Participant accrual
completed
ANZ 7801: Phase III randomised trial to compare endocrine
treatment (oophorectomy) versus cytotoxic chemotherapy
(adriamycin plus cyclophosphamide) versus oophorectomy
plus cytotoxic chemotherapy in premenopausal patients with
advanced breast cancer.
June 1978
November 1981
ANZ 7802: Phase III trial to evaluate hormone therapy
(tamoxifen) versus cytotoxic chemotherapy (adriamycin plus
cyclophosphamide) versus hormone therapy plus cytotoxic
chemotherapy as first line therapy in postmenopausal patients
with advanced breast cancer.
June 1978
November 1981
LBCT I–IV: These protocols compared alternative adjuvant
therapies combining endocrine and cytotoxic chemotherapy for
patients with node-positive operable breast cancer.
July 1978
September 1981
LBCT V: Perioperative and conventionally timed chemotherapy
in operable breast cancer.
November 1981
December 1985
ANZ 8102: Phase III trial to evaluate optimal endocrine
treatment with oophorectomy and tamoxifen in premenopausal
patients with advanced breast cancer.
February 1982
June 1983
ANZ 8101: Phase III trial to evaluate continuous versus
intermittent combination chemotherapy in advanced
breast cancer.
June 1982
June 1985
Systemic Therapy Trials
36
Opened by the
ANZBCTG
Participant accrual
completed
IBCSG VI–VII: Adjuvant therapy in node-positive patients with
operable breast cancer.
July 1986
April 1993
ANZ 8613: Phase III trial to evaluate addition versus
substitution endocrine therapy in advanced breast cancer.
March 1987
September 1993
ANZ 8614: Phase III randomised trial to evaluate single
agent (MTZ) versus combination (CMFp) cytotoxic therapy in
January 1988
June 1993
IBCSG IX: Adjuvant therapy in node-negative
postmenopausal patients with operable breast cancer.
October 1988
August 1999
ANZ 8811: Phase III trial to compare the efficacy of ovarian
suppression treatment with LH-RH agonist, goserelin
(Zoladex®), versus combined Zoladex® plus anti-oestrogen
therapy, Nolvadex® (tamoxifen), in pre and perimenopausal
patients with advanced breast cancer.
February 1989
October 1991
IBCSG VIII: Adjuvant therapy in premenopausal and
perimenopausal patients with node-negative breast cancer.
March 1990
October 1999
IBCSG 11-93: Ovarian ablation followed by tamoxifen with or
without 4 cycles of AC as adjuvant therapy for premenopausal,
node-positive, hormone receptor-positive breast cancer
patients who are suitable for endocrine therapy alone.
May 1993
November 1998
IBCSG 12-93: Tamoxifen for 5 years versus toremifene for
5 years with or without chemotherapy as adjuvant therapy
for postmenopausal and perimenopausal, node-positive,
hormone receptor-positive breast cancer patients.
May 1993
February 1997
IBCSG 13-93: ACx4 followed by CMFx3 with or without a
chemotherapy-free interval, +/- tamoxifen for premenopausal
patients with node-positive breast cancer who are not suitable
for endocrine therapy alone.
May 1993
August 1999
IBCSG 14-93: ACx4 followed by CMFx3 with or without a
chemotherapy-free interval, +/- tamoxifen versus toremifene
for postmenopausal and perimenopausal patients with
node-positive breast cancer who are not suitable for
endocrine therapy alone.
May 1993
August 1999
ANZ 9311: Phase III trial to compare the effect of a short
high-dose intensive course of chemotherapy with filgrastim
support versus a conventional standard-dose course of
chemotherapy in patients with advanced breast cancer.
April 1994
July 1998
IBCSG 15-95: Randomised trial of high-dose chemotherapy
versus standard chemotherapy for high-risk, operable, stage
II and stage III breast cancer in premenopausal and young
postmenopausal patients.
July 1995
March 2000
37
Opened by the
ANZBCTG
Participant accrual
completed
ANZ 9602 (ATLAS): Adjuvant tamoxifen longer against shorter
clinical trial in early breast cancer.
November 1995
March 2005
IBCSG 16-98 / BIG 2-97 (Intergroup Exemestane Study):
Randomised double-blind trial in postmenopausal women with
primary breast cancer who have received adjuvant tamoxifen
for 2–3 years, comparing subsequent adjuvant exemestane
treatment with further tamoxifen.
November 1997
February 2003
ANZ 9801 (ATAC): A randomised double-blind trial comparing
Arimidex® alone with Nolvadex® alone with Arimidex®
and Nolvadex® in combination, as adjuvant treatment in
postmenopausal women with breast cancer.
April 1998
June 1999
IBCSG 17-98 / BIG 3-97 (HABITS): A randomised clinical trial
concerning hormonal replacement therapy (HRT) after previous
radical breast cancer treatment.
August 1998
January 2004
IBCSG 20-98 / BIG 2-98: An intergroup phase III randomised
trial to evaluate the activity of docetaxel, given either sequentially
or in combination with doxorubicin, followed by CMF, in
comparison to doxorubicin alone or in combination with
cyclophosphamide, followed by CMF, in the adjuvant treatment
of node-positive breast cancer.
August 1999
June 2001
IBCSG 18-98 / BIG 1-98: A phase III study to evaluate letrozole
as adjuvant endocrine therapy for postmenopausal women with
receptor (ER and/or PgR) positive tumours.
October 1999
May 2003
ANZ 0001: A phase III trial to evaluate oral chemotherapy with
capecitabine versus standard chemotherapy with CMF for
October 2000
July 2005
ANZ 0101 / BIG 1-01 / IBCSG 28-02 / B016348F (HERA): A randomised three-arm multicentre comparison of 1 year and
2 years of Herceptin®, versus no Herceptin® in women with
HER2-positive primary breast cancer who have completed
adjuvant chemotherapy.
December 2001
January 2005
ANZ 0102 / BCIRG 007: A multicentre phase III randomised trial May 2002
comparing docetaxel (Taxotere®) and trastuzumab (Herceptin®)
with docetaxel (Taxotere®), carboplatin and trastuzumab
(Herceptin®) as first line chemotherapy for patients with
metastatic breast cancer containing the HER2 gene amplification.
ANZ 0201 / 1839IL / 0067 (TIBER): A multicentre open-label,
non-comparative, two-arm, phase II trial of ZD1839 (IRESSA™)
in patients with hormone-insensitive (ER and PgR-negative)
or hormone-resistant (ER and/or PgR-positive) metastatic or
inoperable locally advanced breast cancer.
38
June 2002
March 2004
September 2004
Opened by the
ANZBCTG
Participant accrual
completed
IBCSG 27-02 / BIG 1-02 / NSABP Trial B-37: A randomised
clinical trial of adjuvant chemotherapy for radically resected
loco-regional relapse of breast cancer.
July 2003
January 2010
IBCSG 24-02 / BIG 2-02 (SOFT): A phase III trial evaluating the
role of ovarian function suppression and the role of exemestane
as adjuvant therapies for premenopausal women with
endocrine-responsive breast cancer.
May 2004
June 2010
IBCSG 25-02 / BIG 3-02 (TEXT): A phase III trial evaluating
the role of exemestane plus GnRH analogue as adjuvant
therapy for premenopausal women with endocrine-responsive
breast cancer.
May 2004
March 2011
IBCSG 26-02 / BIG 4-02 (PERCHE): A phase III trial
evaluating the role of chemotherapy as adjuvant therapy for
premenopausal women with endocrine responsive breast
cancer who receive endocrine therapy.
May 2004
December 2006
IBCSG 30-04 / NCIC CTG MA.27: A randomised phase III trial
of exemestane versus anastrozole in postmenopausal women
with hormone receptor-positive primary breast cancer.
May 2005
December 2006
IBCSG 32-05 / BIG 1-05 (CASA): Phase III trial evaluating
the role of adjuvant pegylated liposomal doxorubicin (PLD,
Caelyx®, Doxil®) for women (age 66 years or older) with
endocrine-nonresponsive breast cancer who are not suitable
for being offered a “standard chemotherapy regimen”.
November 2005
November 2007
ANZ 0601 / CIRG / TORI 010: A randomised phase II trial
of double-blind, placebo controlled AMG 706 in combination
with paclitaxel, or open-label bevacizumab in combination with
paclitaxel, as first line therapy in women with HER2-negative
locally recurrent or metastatic breast cancer.
June 2006
July 2008
ANZ 0702 / BIG 2-06 (ALTTO): A randomised, multi-centre,
open-label phase III study of adjuvant lapatinib, trastuzumab,
their sequence and their combination, in patients with
HER2/ErbB2-positive primary breast cancer.
June 2007
July 2010
ANZ 0901 (TAILORx): A phase III, multicentre, multinational,
randomised trial of adjuvant chemotherapy plus hormone
treatment versus adjuvant hormone treatment alone for patients
with previously resected, axillary node-negative, invasive breast
cancer with various levels of risk for recurrence.
October 2009
October 2010
39
40
Communication Report
In the last 12 months, significant progress has been made to strengthen the ANZBCTG’s brand and position
and includes the establishment of the Communications Manager role to drive these activities.
My responsibilities include developing and implementing a Communications Plan, managing the Group’s
media communications and developing an internal communications strategy.
I am excited to be part of this new chapter for the Group and the unveiling of our new logo in the 2010/2011
Annual Report.
The Communications Plan
The Board approved a Communications Plan for the Group which outlines the communication objectives
for the ANZBCTG over the four year period from 2010-2014. The Plan complements the Strategic Planning
Framework, and the priority area of Brand and Position, by providing awareness, relevance, focus and
direction to the manner in which the Group communicates and informs its stakeholders.
The Group’s communication goals include:
■■
■■
■■
■■
■■
■■
To encourage participation in the Group’s clinical trials research program and promote the importance of
this program to eradicate breast cancer;
To develop and implement a dynamic branding strategy across all communication collateral, which
visually represents the Group’s identity and values;
o engage all members by seeking their participation and feedback, promoting and rewarding their work,
T
and providing opportunities to exchange and grow ideas to enrich their membership experience;
To improve the link between the ANZBCTG and the BCIA and stakeholder knowledge of this link;
To promote clinical trial recruitment, encourage participation and develop consumer education materials
about ANZBCTG activities and clinical trial research;
To promulgate relationships with other relevant breast cancer organisations and other clinical trials
research groups.
The ANZBCTG values all stakeholders, both internal and external, and their contribution and support of
our activities. The Communications Plan provides clarity and consistency as to the content and methods of
distributing all communication to our stakeholders.
2010/2011 Initiatives
In the first year of the Communications Plan, the priority areas were:
■■
An audit of all communication collateral;
■■
The development of a new logo;
■■
The development of a Communications Plan;
■■
Commence systems for membership feedback.
Logo
The development of a new logo for the Group tells a story about our past, present and future.
For more than 30 years, the ANZBCTG has played an important role in breast cancer research and has
41
provided the framework for researchers to make significant contributions to the development of and accrual
to international and ANZBCTG led clinical trials. Many of these trials have achieved practice changing
advancements in the prevention and treatment of breast cancer. Our fundraising and education division,
the BCIA, has communicated the importance of the ANZBCTG clinical trials research program to the wider
community, successfully increasing public funding for our research.
Today, the ANZBCTG represents a distinguished collaboration of researchers, working with consumers and
women who participate in our clinical trials, together with committed donors, sponsors and funders who
support our vital research activities. Our Group has grown substantially, in membership and staff, our trial
portfolio, and in community participation and support for our research.
The new logo acknowledges our past achievements, represents who we are today and anticipates our future
successes. It modernises our branding and lays the foundation for improving and streamlining all ANZBCTG
communications. Below is the new ANZBCTG logo and this look also carries through to the BCIA.
Summary
The Communications Plan aims to improve recognition of the ANZBCTG and our work, to acknowledge
the achievements and support of all of our stakeholders, and to modernise our communication collateral
and processes.
The new logo will be introduced to all of the Group’s communications over the next year, including our
website which will combine both ANZBCTG and BCIA activities into a single site. This will acknowledge and
pay tribute to the relationship between our researchers, women who participate in our clinical trials program
and our donors and sponsors.
I look forward to working with our dedicated staff and our stakeholders to achieve all of the Group’s
communication goals.
Anna Fitzgerald
Communications Manager
42
Consumer Advisory
Panel Report
Seventeen years ago, one breast cancer survivor was invited to provide a consumer perspective to the research
programs of the ANZBCTG. Within five years, the ANZBCTG Board of Directors had established a Consumer
Advisory Panel (CAP) because they recognised the value of having consumer input to the planning and conduct
of clinical trials research. Today, CAP has seven members and we are committed to the ANZBCTG research
program and its potential to benefit all women diagnosed with breast cancer, and those at risk.
The aims of CAP are to advocate for women who have participated, or are participating, in breast cancer
clinical trials; help raise community awareness of breast cancer clinical trials and research; represent
consumer views on behalf of the ANZBCTG in government and the community; and importantly, provide the
ANZBCTG with a consumer perspective on relevant issues about clinical trials including recruitment, patient
information for informed consent, new trial protocols and ethical issues.
Today, the input and insights provided by CAP members, most of whom have participated in an ANZBCTG
clinical trial, remain integral to the research programs of the ANZBCTG. Three CAP members are members of
the Scientific Advisory Committee (SAC) thereby ensuring a consumer perspective is provided from the very
early planning stages of a clinical trial.
All protocols and relevant research documents, in particular patient information and consent forms, are
reviewed by CAP. Communication is open between CAP members and ANZBCTG researchers resulting in
improved patient materials providing more clarity and understanding for potential new clinical trial participants.
CAP members participate on ANZBCTG committees, represent the ANZBCTG on external committees, and
independently contribute to many breast cancer advocacy, research and support initiatives.
Clinical Trial Activities
In addition to participating in the SAC Subcommittees, during the reporting period CAP members reviewed
the protocols and patient information materials for the new ANZBCTG initiated SORBET and PROSPECT
trials. We provided a letter of endorsement for the PROSPECT trial to accompany an ethics submission made
by the institution conducting this study, and also provided feedback to the IBIS-I prevention study annual
questionnaire and the LATER video produced as a new recruitment strategy for this trial.
We firmly believe in Quality of Life assessments for appropriate clinical trials and, together with the researchers
of the ANZBCTG, CAP has helped to ensure these substudies are considered when new trials are developed.
Membership
CAP members during the reporting period were Jennifer Bryce, Raewyn Calvert, Sheryl Fewster, Cheryl
Grant, Linda Reaby, Carol Whiteside and Leonie Young (Chair).
We are active in the following ANZBCTG committees and external committees on behalf of the ANZBCTG:
■■
J ennifer Bryce: ANZBCTG Scientific Advisory Committee; ANZBCTG Local Therapy Subcommittee; BIG
3-07/TROG 07.01 Steering Committee.
■■
Raewyn Calvert: ANZBCTG PROSPECT Steering Committee.
■■
Sheryl Fewster: ANZBCTG Supportive Care Subcommittee.
■■
Cheryl Grant: ANZBCTG Systemic Therapy Subcommittee; Patient representative for Australasia: ALTTO
International Steering Committee; ANZBCTG SORBET Steering Committee; Reference Group of the Joint
Consumer Advisory Group of Primary Care Collaborative Cancer Clinical Trials Group and the Psychooncology Co-operative Research Group.
43
■■
■■
■■
Linda Reaby: ANZBCTG Scientific Advisory Committee; ANZBCTG Steering Committees: ANZ 0501
LATER, IBIS-II, ANZ 0502 (Neo-Gem).
Carol Whiteside: Steering Committee for a proposed TROG locally advanced breast cancer study.
Leonie Young: ANZBCTG Scientific Advisory Committee; Chair, Cancer Trials Consumer Network;
SNAC I and II Steering Committees; Reference Group of the Joint Consumer Advisory Group of Primary
Care Collaborative Cancer Clinical Trials Group and the Psycho-oncology Co-operative Research
Group; Community Reference Group, Register4 – a National Research Register of the National Breast
Cancer Foundation.
Advocacy Activities
CAP activities extend beyond ANZBCTG clinical trial protocol review. We are actively involved in promoting
the ANZBCTG research program by acting as media spokespeople in relation to current and specific research
issues, community awareness activities for clinical trials research and in fundraising initiatives of the Breast
Cancer Institute of Australia. This has included guest speaker presentations and sharing personal stories for
specific fundraising projects, such as the Commonwealth Bank Third Party Banking functions held throughout
Australia in October 2010.
The longevity of CAP and its significant contributions to the research program of the ANZBCTG means it is
well experienced to take a lead role in helping newly emerging cancer consumer advisory groups.
Other cancer clinical trials groups in Australia who already involve consumers in their research, or who are
planning to, acknowledge the benefits of sharing knowledge in the area of consumer training and advocacy.
As a result, the Cancer Trials Consumer Network was established recently and consists of consumer
representatives from each of the cancer clinical trials groups. I was elected Chair of this Network and am
delighted to help lead and shape this new and important initiative.
Cheryl Grant and I were invited to join the Reference Group for the Joint Consumer Advisory Group of the
Psycho-oncology Co-operative Research Group and Primary Care Collaborative Cancer Clinical Trials Group.
Our advice and guidance was sought in sourcing appropriate consumers for their Joint Consumer Advisory
Group, and to help mentor and participate in training programs for their consumers.
A poster abstract submitted by CAP about the ANZBCTG initiative IMPACT - Improving Participation and
Advocacy for Clinical Trials - was accepted for presentation at the 2010 Clinical Oncological Society of
Australia Meeting.
CAP members understand the importance of being proactive in seeking opportunities to update and expand
their knowledge and understanding about breast cancer and research. In December 2010, Linda Reaby
received sponsorship through the Alamo Breast Cancer Foundation to attend its Patient Advocate Program
at the San Antonio Breast Cancer Symposium in the United States. In February 2011, Cheryl Grant received
sponsorship to attend the National Breast Cancer Coalition’s premier science and advocacy training program,
Project LEAD in Mexico, USA.
CAP members have a proven record in successful advocacy and a true commitment to the clinical trials
research process. This, combined with our extensive networks, professional skills and experience guarantees
we are a valuable resource for ANZBCTG members.
Leonie Young
Chair, Consumer Advisory Panel
CAP Members in 2010, l-r: Leonie Young, Carol
Whiteside, Jennifer Bryce, Linda Reaby, Cheryl
Grant and Sheryl Fewster. Absent: Raewyn Calvert.
44
Fundraising and
Education Report
I am very pleased to advise that the Breast Cancer Institute of Australia (BCIA), the fundraising and education
department of the ANZBCTG, has experienced another successful year. Our income from donations,
corporate support and special events and projects reached $4.6 million, whilst our costs to fundraise
decreased to 25%.
We are indebted to the Australian community whose generosity remains constant despite the continuing
challenges of the global financial environment.
■■
Income
Expenditure
Net Profit
$4,649,570
$1,157,259
$3,492,311
Fundraising income does not include income from bequests ($113,355).
Fundraising and Operational Strategy
During the reporting period we have continued to grow our database of donors via acquisition strategies
such as our Mother’s Day Campaign and other targeted mailings. Ongoing analysis of these campaigns is
essential to drive future acquisition and to ensure these communications are cost-effective, thoughtful and
well received.
Engaging our donors is a high priority and we undertake considerable research, development and planning
of communications to refine and respond to the needs of our donors. Personalised, effective and efficient
communications, which are received at the time and in the form our donors choose, are vital. Our aim is to
build lasting relationships with our donors that acknowledge their commitment to our research and its success.
The BCIA plans to increase its capacity over the next 12 to 18 months. The establishment of new roles to
support our existing positions will help us to maximise the potential of our current fundraising activities and lay
the foundations for future growth.
Fundraising Highlights
It is with sincere gratitude that I acknowledge and thank Avon, its Representatives and customers for the
recent donation of $500,000 raised via sales of Avon Pink Ribbon Products in 2010. This brings the total
donated from Avon to the ANZBCTG to $6.85 million since 1996 – a remarkable achievement.
The Avon Pink Ribbon Products retail for just $3.99 and Avon Representatives receive no commission on
their sale. It is extraordinary to think that such a large donation can come from so many small purchases and
shows the power of individuals working together. Avon is to be congratulated for providing its customers and
Representatives the opportunity to truly make a difference.
Our partnership with the Commonwealth Bank is also very rewarding and continues to grow, with the Bank
helping to raise $2.35 million since 1995. The Bank is very active in its support of our activities, in particular
The Australian Women’s Health Diary. This year for the first time the Bank sold the 2011 diary in its entire
network of 1,000 branches nationally.
I would like to acknowledge the personal effort of Commonwealth Bank staff who not only enthusiastically sell
and purchase our diary each year, but who also embraced the Pink Morning Tea activity in 2010 by holding
400 events and raising over $90,000.
45
In addition, the Bank’s Third Party Banking (mortgage broker network) division far surpassed their goal this
year raising $143,000 from events they hosted throughout Australia. I know how much work was involved in
organising these events, and am very grateful to the team for their efforts on our behalf.
The 2011 Australian Women’s Health Diary enjoyed great success raising net $930,000 bringing the total
raised to $7 million. Such consistent sales and income provide us with confidence that this product is relevant
and well supported by the community. I am grateful to all our sponsors, and to everyone who purchased the
2011 edition. In particular, my thanks go to the dedicated team at The Australian Women’s Weekly led by Jo
Wiles, AWW Deputy Editor, for their advice, expertise and commitment to the success of every edition.
Education
An important role of the BCIA is to facilitate knowledge and understanding of breast cancer clinical trials
research in the wider community. IMPACT – Improving Participation and Advocacy for Clinical Trials – is
a program for consumers, in particular those who have participated in ANZBCTG clinical trials. There are
over 1,500 members of IMPACT throughout Australia and New Zealand. These members are kept informed
regularly via email of ANZBCTG research and progress, and the IMPACT Newsletter editions 16 and 17 were
provided to members during the reporting period.
In Summary
The recent decision to introduce a new logo for the ANZBCTG and BCIA is exciting and I look forward to
implementing this new look across all BCIA communications over the coming year. The new logo, shown
below, encompasses what our organisation represents today and, by including the colour pink, highlights the
depth of our collaborations – researchers working with donors and sponsors to achieve research progress for
the benefit of our entire community.
I am fortunate to work with a wonderful group of people who work hard to achieve the best outcomes
and are genuinely committed to “a world without breast cancer”. I congratulate the BCIA staff on another
successful year and thank them for their efforts.
We know that the time taken to complete a clinical trial is directly related to the budget available. Our
challenge is to develop cost-effective fundraising activities that have the potential to provide sustainable, long
term income and which resonate strongly with the community. We embrace this challenge with passion and
commitment and look forward to the year ahead.
I am humbled by the ongoing generosity of so many during the past year. My sincere thanks go to the many
thousands of individual donors, community groups and clubs, small and large businesses, schools and
well-known corporate identities. Please be assured we are very grateful for your commitment to the
ANZBCTG research program and we acknowledge the incredible difference your support makes.
Julie Callaghan
General Manager
46
Fundraising Achievements
and Highlights
Donations
We are very fortunate to have a solid base of committed donors throughout Australia and their ongoing
generosity is essential to our research programs and their progress. Donations from individuals during
the past year raised 52% of our overall fundraising income, and donor engagement is a high priority.
Understanding motivations to give and identifying better communication methods is important and work in
this area continues. Our aim is to ensure our donors are acknowledged for their support, informed of our
progress, and communicated to in the manner and at the time they wish.
■■
2007
2008
2009
2010
2011
$2,267,499
$2,680,075
$2,844,488
$2,443,476
$2,285,263
The above does not include Bequest Income ($113,355)
Eight appeals were conducted to existing and potential
new donors during the reporting period and two of these
appeals included our bi-annual newsletter, Editions 24 and 25,
which provided an update on our research progress
and fundraising activities.
We continue to develop the Regular Giving Program which
encourages donors to commit to a regular, automated monthly
donation using their credit card or via a direct debit from
a nominated bank account. A 13% growth in membership
has been achieved during the reporting period resulting in an
additional 12% of income from the previous year. Giving in this way considerably reduces our administrative
costs, and importantly, allows us to plan ahead and take advantage of research opportunities as they arise.
Another successful Mother’s Day Campaign in 2010 secured many new donors and raised significant
funding for our research programs. The Community Service Advertisements promoting this Campaign were
successful in gaining excellent television and radio exposure. In addition, we were also able to secure
advertisements and editorial in many women’s magazines and in metropolitan and regional
newspapers. Our corporate partners contributed with the Commonwealth
Bank promoting the Campaign to their staff nationally, and The
Australian Women’s Weekly including the Campaign on its website.
People responded to the campaign by making a donation in lieu of a
Mother’s Day gift and each received a special Mother’s Day card to give
to their mother or someone special. Website traffic was high this year
with over 86% of respondents choosing to make their donation online.
The Bequest Program is an important activity and we provide regular information and advice to existing
donors and potential new bequestors to encourage them to leave provision in their will for the BCIA. For
many of our long term donors, leaving a bequest ensures that their commitment to our research continues
beyond their lifetime. We also regularly provide bequest information to solicitors and other relevant legal
publications to assist people when making or updating their wills.
47
Bequest income grew substantially during the reporting period, and we gratefully acknowledge:
■■
Estate of the late Thomas Lewis Davies
■■
Estate of the late Marianne Lowen
■■
Estate of the late Michael Craig Wolf
■■
Estate of the late Mary Allen
■■
Estate of the late Noel Ashley Smith
■■
Estate of the late Mary Josephine Wilks
■■
Estate of the late Walter Donald Couper
■■
Estate of the late Laurence Geoffrey Bowes
■■
Estate of the late Louisa Solomon
The BCIA website plays a very important role in promoting ANZBCTG research programs, keeping our
donors informed and engaged, and providing a quick and efficient method of donating online. Plans to
improve the functionality of our website are underway, together with strategies to improve the online position
of the BCIA and increase traffic to our website.
Fundraising activity on the website during the past financial year is shown below.
Merchandise purchases
48
Donations received from
new donors
Donations received from
existing donors
Registration for
Avon race for research
Special Events and Projects
Special events and other projects conducted by the BCIA during the reporting period have raised 34% of
our overall fundraising income. We are very pleased with this result and delighted that many of our long term
activities, such as The Australian Women’s Health Diary, continue to be well supported by the community.
Special events and projects provide us with the opportunity to connect with many different audiences, helping
to promote our research activities and to encourage long term support.
2007
2008
2009
2010
2011
$915,997
$1,154,075
$1,445,927
$1,601,509
$1,586,997
Australian Women’s Health Diary
The Australian Women’s Health Diary is a unique project of the BCIA which was
first produced for the 1999 calendar year. The 2011 edition marks 13 years of this
wonderful resource which has exceeded all expectations and raised net $7 million to
date helping to support our research program and contributing significantly to our
progress. The 2011 edition was successful in generating a net profit of $930,000 and
we are thrilled with this result given the significant downturn in sales of books, diaries
and magazines experienced in the retail sector over the past few years. It shows us
that community support for our diary is strong and that buyers value its features and
the essential health information it contains.
The Australian Women’s Weekly produces the diary on our behalf, and we are
indebted to the creative and production teams who continue to improve the diary
each year keeping it relevant, attractive and informative to existing and potential new buyers.
We are also grateful for the long term commitment of our other major sponsors, Avon and the
Commonwealth Bank. The Commonwealth Bank sold the 2011 edition in every branch nationally resulting
in a marked increase in sales. Our thanks also go to Chris Bath (pictured), Channel 7 news anchor, for her
personal support of our diary.
The Commonwealth Bank helped us launch the 2011 edition at the Hornsby NSW branch of the
Commonwealth Bank on 1 October 2010 with Carol Whiteside, a member of the ANZBCTG Consumer
Advisory Panel, as the special guest.
Carol Whiteside, ANZBCTG Consumer Advisory Panel member, with
Jo-Anne James, Branch Manager of the Commonwealth Bank Hornsby.
49
Golfers ready to Tee Off at Macquarie Links Golf Club.
Tewantin-Noosa golfers keeping the
pink ball in play.
Tee Off for Breast Cancer Research
The Tee Off for Breast Cancer Research event was well supported throughout Australia with golfers taking
to the greens in 2010 raising $130,000. Some 315 golf clubs, both large and small, contributed to this
wonderful result. Since its inception 15 years ago, Tee Off has now raised $1 million for our research
programs – a milestone worth celebrating!
Golf clubs elect a day, or a number of days, in their event calendar to ‘Tee Off’ with the format of the day
planned by each club. In 2010, many clubs unable to hold an event made a donation instead or purchased
Tee Off merchandise.
Each year clubs devise new and innovative ideas to enhance their Tee Off event and we have received some
wonderful photos and stories from Tee Off events held throughout the country. In 2010, clubs enthusiastically
embraced the pink theme by decorating golf carts, buggies, greens and even club houses. Many ladies also
opted to dress the part, with the pink hula ‘Baringhup Belles’ of Maldon Golf Club VIC and the pink wigged
ladies of Wauchope Golf Club NSW.
For a gold coin donation, the ladies of Mundubbera Golf Club QLD could have one of the club’s male golf
professionals ‘substitute’ and play one shot per hole for them – raising a tidy sum to contribute to the overall
funds raised. Over 100 lady golfers competed at the Tewantin-Noosa Golf Club QLD event, with each team
given one pink ball to use throughout the 18 holes. In addition to trying to score maximum points to win
sponsored prizes, each team had to finish the day with their pink ball. As shown in the photo above, some
teams went to great lengths to keep their “pinkie” in play!
We sincerely thank all golf clubs and their members because every donation received, no matter the size, is
very important to our research for the treatment, prevention and cure of breast cancer.
We congratulate the following clubs who were particularly successful in their 2010 events:
■■
Macquarie Links Golf Club, NSW
$8,806
■■
Hervey Bay Golf and Country Club, QLD
$7,500
■■
Richmond Golf Club, NSW
$6,430
■■
Gosford Golf Club, NSW
$4,470
■■
Mornington Golf Club, VIC
$3,781
■■
Tallwoods Golf Club, NSW
$3,717
■■
Elanora Golf Club, NSW
$3,390
The pink hula “Baringhup Belles” from
Maldon Golf Club VIC.
50
Pink wigs galore at Wauchope Golf Club NSW.
Ardrossan Golf Club SA “pink ladies”.
Avon race for research
The sun may not have been smiling on Sunday 24 October, but there were still plenty of
smiling faces at the 2010 Avon race for research. This 5km fun run and walk was held
on the Newcastle Foreshore NSW and is a special way for people to remember those
they have lost to breast cancer, or to celebrate their own survivorship or that of a family
member or friend.
More than 2,660 people pre-registered for the 2010 event, and despite the unwelcoming
weather conditions, 1,500 people braved the cold, wet, windy day to participate.
It was heartwarming to see the spirit and enthusiasm of the women, men and children who tackled the 5km
course and their efforts were certainly rewarded with the event raising $74,000.
Many people also took the opportunity to encourage family and friends to sponsor their participation in
the event. The Newcastle Permanent Sponsorship Challenge is a very important component to our event
and contributes significantly to the overall monies raised. Using the My Sponsorship Challenge section of
the website, entrants could email their sponsors requesting support and keep a track of their sponsorship
tally. For the second year in a row, Michelle Wiseman of Wangi Wangi NSW won the Newcastle Permanent
Sponsorship Challenge, collecting $3,864 in sponsorship monies.
An online message board was introduced this year and many entrants left special messages explaining why
they were participating and also encouraging others to participate.
Over 120 wonderful volunteers gave their time on race day to assist in the organisation, and our thanks
extend to our many sponsors who provided fantastic prizes, essential equipment and valuable
promotional support.
Everyone who splashed their way across the finish line received an Avon sunscreen and lip balm compliments
of Avon. Our special thanks also go to our other major sponsors Newcastle Permanent, The Herald, Radio
Newcastle NXFM and Southern Cross Ten.
51
Community Fundraising
We are delighted to be regularly approached by individuals, community groups and clubs, schools and
businesses wishing to conduct special events on our behalf. Our Fundraising Guidelines and Application
Form are supplied and authorities issued to govern these important relationships.
These events, large and small, require a dedication of time and a generosity of spirit to successfully organise.
We are very grateful to all those who have supported the BCIA in this way during the reporting period:
Liam Alderson, Speers Point NSW
Suzy Connor, Kenmore QLD
Beth and James Dooley, Croydon VIC
May Lam, Doncaster NSW
Dianne Piazza, Miranda NSW
Faye Purnell, Buttaba NSW
Beverly Sines, Carindale QLD
Kay Wahlstedt, Cardiff NSW
Sarah Wawrzkowicz, Seven Hills NSW
Allsafe Insurance Brokers, Stones Corner QLD
Andorra Australia, Heidelberg West VIC
Centrelink – National Families and Child Care Processing Team, Wickham NSW
Commonwealth Bank, Melbourne VIC
Commonwealth Bank, Marion SA
Commonwealth Bank, Kenmore QLD
Commonwealth Bank Graduate Committee, Sydney NSW
Commonwealth Bank Summer Intern Community Committee, Sydney NSW
Commonwealth Collections Contact Centre, Melbourne VIC
Church of the Good Shepherd Handcraft Group, Cardiff NSW
Dobroyd Point Public School – Starbroyds, Haberfield NSW
Dungog Sunshine Club, Dungog NSW
Folk and Decorative Artists of Australia Incorporated, Newport Beach NSW
Glen Waverley Country Women’s Association, Glen Waverley VIC
Group 22 2002, Duns Creek NSW
Hall Payne Lawyers, Brisbane QLD
Suzy Connor and her sons taking part
in the 2010 Suzy Connor Challenge.
52
The ‘Starbroyds’ at their Mother’s Day Stall.
Commonwealth Bank graduates enjoying
themselves at the Trivia Night.
Hendrix Photography, Camp Hill QLD
Hillstone St Lucia, Hillstone QLD
Insulect, Darra QLD
Lions Club of Manly, Manly NSW
Maitland Patchwork Quilters Incorporated, East Maitland NSW
Manning River Dragon Boat Club Incorporated, Taree NSW
Mary’s Melody Makers, Fassifern NSW
Merewether Meat and More, Merewether NSW
Moonta Memorial Bowling Club – Night Owls, Moonta SA
Parents and Citizens’ Association Wamberal Primary School, Wamberal NSW
Parramatta Sovereign Council No 24, Parramatta NSW
Patrons of the Sacred Heart Housie, Newcastle NSW
Pedare Christian College, Golden Grove SA
PVB Couriers, Springfield QLD
Sewing Bees, Salamander Bay NSW
Saint Joseph’s Primary School, Merewether NSW
South of the River Hairdressing, Adamstown NSW
Surrey Hills Primary School, Surrey Hills VIC
Sutherland Shire Montessori School, Gymea NSW
Swansea Combined Pensioners Association Incorporated, Swansea NSW
Swansea Workers Co-Op Club Ltd, Swansea NSW
Taren Point Public School, Taren Point NSW
Uproar Fashion, Belmont NSW
Westpac Banking Corporation, Sydney NSW
Women’s Group of St Mary, Adamstown NSW
WOW! Designer Jewellery, Swansea NSW
Manning River Dragon Boaters in action.
Beth and James Dooley’s beautiful garden. Tamar Carpenter, BCIA (left) with Louise BrownThomas of the Maitland Patchwork Quilters.
53
In Memoriam
Gifts received in memory when a friend or family member dies are a meaningful and lasting way of
commemorating their life and supporting breast cancer research.
The BCIA has special In Memoriam envelopes which are sent upon request to relatives and funeral homes
throughout the year.
The BCIA received many In Memoriam donations during the past financial year.
We sincerely acknowledge donations made in memory of:
Mrs Rhoda Alcock
Mrs Raelene Hutton
Mrs B Allan
Mrs Kathryn Inglis
Mrs Nina Armitage
Mr SK Len Jeans
Mrs Joyce Arnold
Mrs Mary Johnson
Mrs Samantha Baker
Mrs Amelia Johnston
Ms Judy Banfield
Mrs Ann Jory
Ms Rosemary Barrington
Mr Kon Kamci
Ms Pam Bateson
Mrs Anna Kostinas
Mrs Margaret Battishall
Mrs Patricia Kyle
Mrs Moya Beacroft
Mrs Jac Larking
Ms Denise Bird
Mrs Margaret Bond
Ms Beverley Grace Bradford
Mrs Josie Breust
Mrs Fay Brown
Mr Ralph Campbell
Mrs Kathleen Emmie Charlton
Mrs Tess Coffey
Mrs Anna Con
Ms Christine Cooper
Mrs Mary Corcoran
Mrs Jenny Craig
Ms Roslyn Crutcher
Mrs Gwen Cunningham
Mrs Annaliese Druce
Mr Eddie Dunn
Mrs Audrey Eyles
Mrs Rachel Fabian Ymalay
54
Mrs Margaret Lee
Mrs Karen Liolios
Mrs Milena Lopusina Vukcevic
Mrs Sandra Lundy
Ms Tracy McCabe
Mrs Anne Maree McKenna
Mrs Joanne McLean
Mrs Kathleen McManus
Ms Kelly McWhirter
Mrs Ellen Mellios
Ms Pamela Morrison
Lady Joan Muir
Mrs Patricia Natt
Mrs Ellen Needham
Mrs Elizabeth Newman
Mr Emanuel Pace
Mrs Louise Parsons
Mrs Heather Paterson
Mrs Dawn Pearson
Mrs Valda Fridey
Ms May Perkin
Ms Judith Anne Gray
Mrs Jackie Przybylski
Mrs Soula Guzowski
Mrs Debbie Queen
Mrs Helen Hamilton-Smith
Mrs Mavis Rankin
Mrs Jean Hauser
Ms Marjorie Rennie
Mrs Margaret Hay
Mrs Patricia Roughley
Mrs Joan Phyllis Hodgson
Ms Ellen-Mae Sams
Mrs Cheryll Hooker
Mrs Jenni Scobie
Ms Pamela Anne Scott-Webber
Mrs Norma Wales
Mrs Vera Shaw
Ms Monica Ward
Ms Julie Shoullis
Ms Helen Maree Ware
Mrs Denise Simpson
Mr John Warren
Mrs Helen Smart
Mrs Maureen Weaver
Ms Marguarite Stalker
Mrs Kate Webb
Ms Margaret Stevens
Mrs Heather Wells
Mrs Patricia Thornton
Ms Ada Dorothy Whitmore
Mrs Ingrid Todd
Mrs Janice Wilson
Mrs Ninette Trent
Mrs Heather Woodfield
Mrs Kathy Tucker
Ms Pam Woods
Mrs Phyllis Marion Urquhart
Mrs Beverley Elaine Wright
Mrs Rhona Wahlhaus
Ms Pamela Young
In Celebration
Many donors very generously encourage their friends and family to donate
to the BCIA in lieu of gifts for special occasions. Our In Celebration support
packs can be used on these occasions.
We acknowledge the following donors who chose to celebrate
their birthdays, weddings, anniversaries and other special events
in a truly “giving” way.
Mr and Mrs Cyril Ashton
60th Wedding Anniversary
Ms Kathrin Bellairs and Mr Dallas Jarred
Wedding
Mrs Idit Benjamin
50th Birthday
Mr Lloyd Binney
90th Birthday
Mr and Mrs Buck
Wedding
Mrs Kathy Cafe
50th Birthday
Mrs Louise Goodwin
50th Birthday
Miss Gillian Holden
Mother’s Day
Ms Deborah Lee
Christmas
Mrs Marilyn Leunig
Birthday
Ms Tracy McCabe
Christmas
Ms Helen McKirdy
60th Birthday
Mr Paul Meredith
60th Birthday
Ms Rozet Morgan
Birthday
Mrs Linda Rayner
50th Birthday
Mr and Mrs Helmut Regelein
Golden Wedding Anniversary
Mr Vincent Rossitto
50th Birthday
Mr Dale Sebire
40th Birthday
Mr and Mrs B Wallace
Christmas
Mr and Mrs Fred Watson
40th Wedding Anniversary
Mr and Mrs Sarah and Cameron Wolfe
Wedding
55
Corporate Support
We are privileged to have long term corporate partnerships with a number of highly respected and
well-known corporate organisations.
The ongoing strength of our corporate partnerships is testament to our mutual commitment to advancing
progress in breast cancer research for the benefit of all women and their families.
Income from corporate activities raised 14% of our overall fundraising income. Growth in income has
been achieved largely as a result of additional fundraising and other supporter initiatives conducted by the
Commonwealth Bank and its staff.
■■
2007
2008
2009
2010
2011
$553,466
$544,887
$566,534
$675,741
$777,310
This income does not include sponsorship received for the Australian Women’s Health Diary. This is
represented in the Special Events and Projects income.
Avon
We have shared a special partnership with Avon Australia, its Representatives and customers for more than
16 years. Over this time, Avon has donated an incredible $6.85 million to our research programs through the
sale of Avon Pink Ribbon Products.
Thanks to the generosity of Avon Representatives, who do not make any profit from the sale of Pink Ribbon
Products, all monies raised via sales are donated to the breast cancer cause.
We were delighted to welcome Mr Stephen Ford, President and General Manager of Avon Australia and New
Zealand, to the 2010 Avon Race for Research event in Newcastle NSW. Mr Ford presented Professor John
Forbes, ANZBCTG Director of Research, with a donation of $500,000 (pictured). These funds were raised by
the sale of the Avon Breast Cancer Crusade Pin and Kitty (pictured).
Avon generously sponsors our Australian Women’s Health Diary and the Avon race for research. This 5km fun
run/walk held in Newcastle NSW attracted more than 2,600 people in 2010 with each participant receiving a
free Avon sunscreen and lip balm when they crossed the finish line.
Avon also supports our efforts to foster and attract the best, new breast cancer researchers by sponsoring
the Avon Travel Grant program which provides opportunities for breast cancer researchers from throughout
Australia and New Zealand to attend the Annual Scientific Meeting of the ANZBCTG.
56
Commonwealth Bank
Since 1995, the Commonwealth Bank has worked in partnership with the BCIA helping to raise $2.35 million
for our clinical trials research program. Our long term partnership with the Bank is highly valued and we are
grateful for the Bank’s ongoing commitment to our research and our fundraising initiatives.
The Commonwealth Bank sponsors the production of The Australian Women’s Health Diary and provides
essential support in promoting and selling the diary to its staff, customers and the general community. In
2010/2011, the Bank used its entire network of over 1,000 branches nationally to sell the diary to branch
customers resulting in over 10,500 diaries sold.
Commonwealth Bank staff have always been very supportive of our diary and we continue to work with the
Bank to inform Bank staff about our research progress and how their support is helping.
In 2010, Commonwealth Bank staff purchased 5,189 copies of the 2011 diary. The Bank made an additional
matching donation for each diary sold bringing the total raised by Bank staff to over $57,000. Over the past 13
years, a total of $572,000 has been raised via Bank staff sales and the Bank’s matching donation program.
We were delighted that many Bank staff throughout Australia also organised pink-themed events during
National Breast Cancer Awareness Month in October 2010 to raise additional funding for the BCIA. Events
were held in 400 branches raising a remarkable $92,000.
Bowen Branch staff and Surfers Paradise Branch staff pictured at their Pink Morning Tea events.
The Third Party Banking (mortgage broker network) division of the Commonwealth Bank once again hosted
functions throughout Australia in support of the BCIA during the year. High tea events were held in Perth
and Brisbane where guests were treated to fashion parades and market stalls, and had the opportunity to
enter best-dressed, best-hat and most fabulous heels competitions. Evening cocktail parties were held in
Melbourne, Adelaide and Sydney.
Key members of the banking and finance community attended each event and guests were asked to make
a donation upon entry and silent and live auctions were held. The events were very successful raising
$143,000, an increase of $100,000 from the previous year!
Many customers of the Commonwealth Bank have donated to the BCIA or purchased the 2011 Australian
Women’s Health Diary using their reward points. This is a wonderful initiative and we have received many
donations and diary sales as Bank customers take the opportunity to support breast cancer research.
An entry to the best-hat competition.
Designer shoes for sale at the Sydney event.
Kathy Cummings, CBA (right) presents
Julie Callaghan, BCIA with the funds
raised at the state wide events.
57
As part of the 2010/2011 Commonwealth Bank Series, the Hitting Cancer for Six initiative, which is now in its
fifth year, saw the Bank donate $1,000 for every six hit during the Series. A total of 32 sixes were hit, raising
$32,000 and we were delighted to share this with the Prostate Cancer Foundation of Australia (PCFA).
In August 2010, the Commonwealth Bank and Opera Australia teamed up to put on a special performance
of “The Pirates of Penzance” at the Sydney Opera House. The Bank matched the proceeds from ticket sales
with a donation of $11,000 each to the BCIA and the PCFA.
Mike Hussey, Australian cricket player and Commonwealth
Bank cricket ambassador.
Assoc Prof Fran Boyle with the cast of “The Pirates of Penzance”,
together with Alden Toevs, CBA (right) and Adrian Collette, Opera
Australia (far right).
The Australian Women’s Weekly
The Australian Women’s Weekly has produced the Australian Women’s Health Diary on our behalf since the
first edition in 1999. The diary has now raised $7 million which is a vital contribution to our research for the
treatment, prevention and cure of breast cancer.
The diary’s success is largely due to the wonderful team who produce each edition. This team is led by Jo
Wiles, Deputy Editor of The Weekly and brings together expertise in writing, researching, editing, design,
promotion, production and distribution. These elements are fundamental to the diary’s success and we
are very grateful to The Weekly, Jo Wiles and each person who contributes to the diary for their ongoing
enthusiasm and support for this project.
58
Governance and Footprint
The Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) is a collaborative, national and
international breast cancer clinical trials research group. It is a not for profit company limited by guarantee
with strong academic and research links. The organisational structure of the ANZBCTG reflects its corporate
governance and operational areas of responsibility.
A Board of Directors, which comprises six elected Directors and three appointed Directors, governs the
ANZBCTG. The role of the Board is to oversee all aspects of the ANZBCTG’s activities, and the current Board
Chairman is Dr Jacquie Chirgwin.
The ANZBCTG has a number of Board established committees to ensure its research activities are
undertaken to the highest standards. The ANZBCTG Scientific Advisory Committee (SAC) is responsible for
setting the Group’s research direction and is Chaired by Associate Professor Nicholas Wilcken and Vice Chair,
Associate Professor Fran Boyle. The ANZBCTG Director of Research, Professor John Forbes, manages the
scientific and clinical conduct of the clinical trials program in conjunction with the SAC Chair.
A dedicated team of more than 60 personnel, led by the Director of Research and Chief Operating Officer, Dr
Soozy Smith, manage the day to day business of the ANZBCTG at the Group’s central offices in Newcastle
NSW. The Trials Coordination Department, which develops, activates and coordinates all ANZBCTG clinical
trials, is a crucial part of this team.
The ANZBCTG’s Statistical Centre is located at the National Health and Medical Research Council (NHMRC)
Clinical Trials Centre at the University of Sydney. The Statistical Centre provides statistical advice on
new projects, randomisation processes for some current trials and statistical analyses of study results
for publication.
The Breast Cancer Institute of Australia is the fundraising and education department of the ANZBCTG. It is
responsible for providing a source of ongoing funding for the ANZBCTG research program via community and
corporate support, special events and projects. Please also refer to Funders and Supporters, and Sponsors
(page 82).
The important principles for ANZBCTG research are relevant and reliable research data; respect for scientific
integrity; and robust, peer-reviewed scientific processes. All research conducted by the ANZBCTG is carried
out according to:
■■
■■
National and International Guidelines for Good Clinical Practice;
Guidelines of the NHMRC including the National Statement on Ethical Conduct in Research
Involving Humans;
■■
Ethical approvals for each clinical trial; and
■■
All applicable legislation, policies and regulations in Australia and New Zealand.
59
Board of Directors
(31 March 2011)
Dr Jacquie Chirgwin
Dr Jacquie Chirgwin was elected Chair of the ANZBCTG Board of Directors in
2005 having first become a member of the Board in 2003. She is also a member of
the ANZBCTG Scientific Advisory Committee and has had a long commitment to
clinical research spanning more than 20 years. Dr Chirgwin is a Medical Oncologist
at Box Hill and Maroondah Hospitals in Victoria and established breast cancer
clinical trial departments in these hospitals and at the Breast Unit at Mercy Private
Hospital in East Melbourne. She is Chair of the Victorian Cooperative Oncology
Group Breast Cancer Committee and a member of the Reference Group of the
North Eastern Melbourne Integrated Cancer Service. She is also a member of
several international cancer research bodies.
Associate Professor Frances Boyle AM
Associate Professor Fran Boyle was elected to the ANZBCTG Board of Directors
in 2001, is the Vice Chair of the Board and was Chair of the ANZBCTG Scientific
Advisory Committee for five years until November 2010 and is now Vice Chair.
She is a Medical Oncologist and is Associate Professor of Medical Oncology at
the University of Sydney, and Director of the Patricia Ritchie Centre for Cancer
Care and Research at the Mater Hospital, Sydney. Associate Professor Boyle
is also a Board Member of the Breast Cancer Network Australia. She has close
links with health professionals across the spectrum of cancer care and with the
undergraduate teaching program of the University of Sydney. Associate Professor
Boyle was honoured in 2008 with Membership of the Order of Australia for work with
professional and community organisations involved in cancer care and research.
Professor Stephen Ackland
Professor Stephen Ackland was first elected to the ANZBCTG Board of Directors
in 2007, and was appointed a Director in 2010. He is a Medical Oncologist and
Senior Staff Specialist in the Medical Oncology Department of the Calvary Mater
Newcastle, Director of Clinical Cancer Research at Hunter New England Health
and Co-Chair of the Cancer Research Program of Hunter Medical Research
Institute. Other professional activities include Director of the NSW Cancer Council,
Editor-in-Chief of the Asia Pacific Journal of Clinical Oncology and membership of
many national and international cancer research bodies. In 2008 he completed an
Australian Institute of Company Directors course.
Associate Professor Ian Campbell
Associate Professor Ian Campbell was elected to the ANZBCTG Board of Directors
in 2001 and is a member of the ANZBCTG Scientific Advisory Committee. He is a
Surgeon and is the Clinical Director of the Breast Care Centre at Waikato Hospital
in Hamilton, New Zealand. His academic appointment is with the University of
Auckland School of Medicine, Waikato Division, and is based on breast cancer
clinical trials work with a special interest in local therapies and endocrine treatments.
Associate Professor Campbell is Chairman of the Waikato Breast Cancer Trust; he
was Chairperson of the NZ Guidelines Group team producing the NZ Guidelines
for Management of Early Breast Cancer. He is the New Zealand representative on
the RACS Breast Section and Breast SurgANZ and a number of other national and
international breast cancer groups.
60
Ms Melinda Conrad
Ms Melinda Conrad was appointed to the ANZBCTG Board of Directors in 2009.*
She is a consultant and company director for a range of business, health and
community organisations. Her areas of expertise are in strategy, consumer
marketing and service delivery. She currently serves as a non executive director for
the Garvan Institute of Medical Research Foundation, the NSW Clinical Excellence
Commission and the NSW Agency for Clinical Innovation. In her previous
executive career, Ms Conrad founded and managed the retail store chain Conrads
Warehouse, and held management roles at Colgate-Palmolive and Harvard
Business School. She graduated with honours from Harvard Business School and
Wellesley College in Boston. Ms Conrad is also passionate about the arts and
serves on the Board of the Australian Brandenburg Orchestra.
* Retired from the Board in September 2010
Mr Michael Hamar
Mr Michael Hamar was appointed to the ANZBCTG Board of Directors in March
2011. Mr Hamar is a consultant in the field of risk management and banking.
He retired in 2009 from the National Australia Bank, where he was a member of
the Group Executive Committee and Group Chief Risk Officer. Prior to that, Mr
Hamar had a 35 year career in banking and finance, including positions with the
Commonwealth Bank of Australia, JP Morgan Chase and Bank of America in
Europe, the USA, Asia and Australia. He holds Masters degrees from Cambridge
University and the University of Chicago.
Clinical Associate Professor Anne Hamilton
Clinical Associate Professor Anne Hamilton was elected to the ANZBCTG Board
of Directors in 2005. She chairs the Finance and Audit Subcommittee and is a
member of the ANZBCTG Scientific Advisory Committee. She is a consultant
Medical Oncologist at the Peter MacCallum Cancer Centre and Royal Women’s
Hospital in Melbourne, and Clinical Associate Professor at the University of
Sydney. She started her medical career in Melbourne and has held research
and clinical apppointments in Brussels (Institut Jules Bordet / Université Libre
de Bruxelles), New York (Bellevue Hospital / New York University), and Sydney
(Sydney Cancer Centre, Royal Prince Alfred Hospital / University of Sydney). She
has clinical and research interests in the areas of breast cancer, gynaecological
malignancies, melanoma, and developmental therapeutics.
Professor Geoffrey Lindeman
Professor Geoffrey Lindeman is a Clinician-Scientist elected to the ANZBCTG
Board of Directors in 2003 and is also a member of the ANZBCTG Scientific
Advisory Committee. He is a Medical Oncologist at the Royal Melbourne Hospital,
where he heads the RMH Familial Cancer Centre. Professor Lindeman is also
Joint Head of the Stem Cells and Cancer Division at the Walter & Eliza Hall
Institute of Medical Research in Melbourne and Clinical Director of the ACRF
Centre for Therapeutic Target Discovery. He is a current NHMRC Principal
Research Fellow. He is a member of the kConFab Executive (a consortium
studying hereditary breast cancer) and the Victorian Cancer Biobank
Consortium Committee.
61
Mr Stephen Porges
Mr Stephen Porges was appointed to the ANZBCTG Board of Directors in 2010.
He has been the Chief Executive Officer at Aussie since August 2008, having spent
over 20 years in International Banking and Investment Banking throughout Asia,
Europe and the US. His areas of expertise are finance and strategy. Mr Porges was
the Chief Executive Officer at the Newcastle Permanent Building Society and also
spent several years as CEO of listed Biotechnology company Proteome Systems.
Professor John Simes
Professor John Simes has been an ANZBCTG Board Director since 1991. He is
Director of the ANZBCTG Statistical Centre located at the NHMRC Clinical Trials
Centre (CTC) and a member of the ANZBCTG Scientific Advisory Committee.
Professor Simes is a practicing Medical Oncologist at the Royal Prince Alfred
Hospital, Sydney and a Professor of Clinical Epidemiology in the School of Public
Health at the University of Sydney. He is Director of the NHMRC CTC and is
responsible for the CTC’s overall research program.
62
Scientific Advisory Committee (SAC)
(31 March 2011)
Assoc Prof Nicholas Wilcken Chair
Medical Oncologist
Assoc Prof Frances Boyle AM
Vice Chair
Medical Oncologist
Prof Bruce Mann
Chair, SAC Local Therapy Subcommittee
Surgical Oncologist
Prof Phyllis Butow
Co-Chair, SAC Supportive Care Subcommittee
Psycho-Oncologist
Co-Chair, SAC Supportive Care Subcommittee
Medical Oncologist
Dr Prue Francis * Chair, SAC Systemic Therapy Subcommittee
Medical Oncologist
Assoc Prof Richard Bell
Medical Oncologist
Dr Jennifer Bryce
ANZBCTG Consumer Advisory Panel
Assoc Prof Ian Campbell
Surgical Oncologist
Dr Jacquie Chirgwin Medical Oncologist
Assoc Prof Boon Chua Radiation Oncologist
Prof Alan Coates AM Medical Oncologist
Prof John Collins Surgical Oncologist
Assoc Prof Joanna Dewar Medical Oncologist
Prof John Forbes
Surgical Oncologist
Dr Glenn Francis
Pathologist
Prof Val Gebski ANZBCTG Group Statistician
Prof Michael Green Medical Oncologist
Assoc Prof Anne Hamilton Medical Oncologist
Assoc Prof Vernon Harvey Medical Oncologist
Prof David Joseph Radiation Oncologist
Prof Ron Kay Surgical Oncologist
Dr Belinda Kiely
Medical Oncologist
Prof Madeleine King **
Psycho-Oncologist
Dr Marion Kuper-Hommel
Medical Oncologist
Prof Geoffrey Lindeman Medical Oncologist / Clinician-Scientist
Mrs Dianne Lindsay ANZBCTG Trials Coordination Department
Dr Janine Lombard Medical Oncologist
Assoc Prof Nicole McCarthy Medical Oncologist
Dr Gillian Mitchell Medical Oncologist
Adjunct Prof Linda Reaby AM ANZBCTG Consumer Advisory Panel
Assoc Prof Clare Scott
Medical Oncologist / Clinician-Scientist
Prof R John Simes Medical Oncologist / Statistician
Assoc Prof Raymond Snyder Medical Oncologist
Assoc Prof Martin Stockler Medical Oncologist
Prof Rob Sutherland Pathologist
Dr Craig Underhill Medical Oncologist
Ms Leonie Young
* Acting Chair for Assoc Prof Nicole McCarthy on maternity leave.
** Retired from the SAC in February 2011.
63
Independent Data Safety and Monitoring Committee
Prof Martin Tattersall
Chair
Dr Colin Furnival
Assoc Prof Matthew Law
Prof John Zalcberg
Consumer Advisory Panel Members
(31 March 2011)
Leonie Young
Chair
Consumer Coordinator, IMPACT Program
QLD
Jennifer Bryce
VIC
Raewyn Calvert NZ
Sheryl Fewster
WA
Cheryl Grant
NSW
Adjunct Prof Linda Reaby AM
ACT
Carol Whiteside
NSW
Staff Member Listing
(for period 1 April 2010 to 31 March 2011)
64
Heath Badger Team Leader
Lauren Boyes Team Leader
Julie Callaghan BCIA General Manager
Wendy Carmichael Chief Operating Officer
Tamar Carpenter BCIA Special Projects Officer
Joanne Cranch BCIA Fundraising and Finance Officer
Anna Cummins
BCIA Donor Relations Officer
Haley Deacon
Trial Coordinator
Annette Dempsey Trial Coordinator
Donna Douglass Administration Assistant
Robyn Ferrie
Business Administrator – Human Resources
Anna Fitzgerald
Communications Manager
Akiko Kato-Fong Senior Trials Coordinator
Nicole Francis
Administration Assistant
Sharyn Frank Information Support Officer
Helen Garner Personal Assistant to Professor John Forbes
Kellie Gasson Administrative Officer
Sarah Girtchen
BCIA Gift Processing Officer
Rosemary Goodenough Trial Coordinator
Leigh Hainsworth Administrative Officer
Belinda Hansen Senior Trials Coordinator
Linda Hunter Recruitment and Promotions Officer
Juliette Jameson Administration Assistant
Angela Johns Project Officer – Protocol Development
Amy Jongerden
Trial Coordinator
Ingrid Laycock Trial Coordinator
Dr Eugene Leong
Clinical Fellow
Jenny Leggett BCIA Public Relations Manager
Dianne Lindsay Head of Trials Management
Mai Ly
Trial Coordinator
Lauren Macnab Senior Trials Coordinator
Kelly Martin BCIA Donor Development Manager
Carlie Mavin Trial Coordinator
Rebecca Moder Quality Assurance Officer
Rebecca Montgomery
Senior Trials Coordinator
Anthony Morrison Trial Coordinator
Sophia Moscovis
Trial Coordinator
Christine Myers
BCIA Gift Processing Officer
Alison Newton Trial Coordinator
Rose Nguyen Trial Coordinator
Katie Oleksyn Trial Coordinator
Lisa Paksec Ethics and Regulatory Affairs Manager
Louise Plowman
Trial Coordinator
Flonda Probert Senior Trials Coordinator
Stuart Reeves
Trial Coordinator
Hollie Ritchie Trial Coordinator
Kristy Schmidt Project Officer – Ethics and Regulatory Affairs
Lisa Sipple
Business Administrator – Governance
Jessica Smith
Trial Coordinator
Kristy Taubman
Trial Coordinator
Rochelle Thornton
Team Leader
Katie Vullo
Recruitment and Promotions Officer
Angie Ward Trial Coordinator
Christine Wasik Business Administrator – Accounts Receivable
Coralie Watson
Trial Coordinator
Stacey Wilks Business Administrator – Accounts Payable
65
Contact Information
Trials Coordination Department
Australia and New Zealand Breast Cancer Trials Group
PO Box 155
Hunter Region Mail Centre NSW 2310
Australia
Phone: (+61) 2 4985 0136
Fax:
(+61) 2 4985 0141
Email: [email protected]
Web:
www.anzbctg.org
Business Administration Department
Australia and New Zealand Breast Cancer Trials Group
PO Box 283
The Junction NSW 2291
Australia
Phone: (+61) 2 4925 5255
Fax:
(+61) 2 4925 3068
Email:
[email protected]
[email protected]
Web:
www.anzbctg.org
Fundraising and Education Department
PO Box 283
The Junction NSW 2291
Australia
Phone: (+61) 2 4925 3022
1800 423 444
66
Fax:
(+61) 2 4925 3068
Email:
[email protected]
[email protected]
Web:
www.bcia.org.au
Contributors, Members
and Supporters
International Collaborators
Breast International Group (BIG)
Belgium
Breast European Adjuvant Studies Team (BrEAST)
Belgium
Cancer International Research Group (CIRG)
France
Cancer Trials Support Unit (CTSU)
USA
Clinical Trial Service Unit (CTSU)
UK
Cancer Research UK (CRUK)
UK
Eastern Cooperative Oncology Group (ECOG)
USA
International Breast Cancer Study Group (IBCSG)
Switzerland and USA
National Institute of Canada, Clinical Trials Group (NCIC-CTG)
Canada
National Surgical Adjuvant Breast and Bowel Project (NSABP)
USA
Swiss Group for Clinical Cancer Research (SAKK)
Switzerland
Southwest Oncology Group (SWOG)
USA
Participating Institutions
Australian Capital Territory
The Canberra Hospital Capital city – Canberra – Garran
New South Wales
Armidale Hospital
Regional – Armidale
Bankstown–Lidcombe Hospital
Capital city – Sydney – Bankstown
The Breast Centre
City – Newcastle
Calvary Mater Newcastle
City – Newcastle
Coffs Harbour Health Campus
Regional – Coffs Harbour
Concord Repatriation General Hospital
Capital city – Sydney – Concord
Lingard Private Hospital
City – Newcastle
Lismore Base Hospital
Regional – Lismore
Liverpool Hospital
Capital city – Sydney – Liverpool
Macarthur Cancer Therapy Centre
Capital city – Sydney – Campbelltown
Manning Rural Referral Hospital
Regional – Taree
Mater Hospital
Capital city – Sydney – North Sydney
Nepean Cancer Care Centre
Capital city – Sydney – Kingswood
67
Newcastle Private Hospital
City – Newcastle
Port Macquarie Base Hospital
Regional – Port Macquarie
Prince of Wales Hospital
Capital city – Sydney – Randwick
Riverina Cancer Care Centre
Regional – Wagga Wagga
Royal Hospital for Women
Capital city – Sydney – Randwick
Royal North Shore Hospital
Capital city – Sydney – St Leonards
Royal Prince Alfred Hospital
Capital city – Sydney – Camperdown
St George Hospital
Capital city – Sydney – Kogarah
St Vincent’s Hospital
Capital city – Sydney – Darlinghurst
Southern Highlands Cancer Centre
Regional – Bowral
Sydney Haematology & Oncology Clinic
Capital city – Sydney – Wahroonga
Tamworth Rural Referral Hospital
Regional – Tamworth
The Tweed Hospital
Regional – Tweed Heads
Westmead Hospital
Capital city – Sydney – Westmead
Queensland
HOCA @ Wesley
Capital city – Brisbane – Auchenflower
Mater Adult Hospital
Capital city – Brisbane – South Brisbane
Nambour Hospital
Regional – Nambour
Princess Alexandra Hospital
Capital city – Brisbane – Woolloongabba
Royal Brisbane and Women’s Hospital
Capital city – Brisbane – Herston
St Andrew’s Toowoomba Hospital
Regional – Toowoomba
Toowoomba Hospital
Regional – Toowoomba
Townsville Hospital
Regional – Townsville
The Wesley Breast Clinic
Capital city – Brisbane – Auchenflower
South Australia
Ashford Cancer Centre
Capital city – Adelaide – Ashford
Flinders Medical Centre
Capital city – Adelaide – Bedford Park
The Queen Elizabeth Hospital
Capital city – Adelaide – Woodville South
Royal Adelaide Hospital
Capital city – Adelaide
St Andrew’s Medical Centre
Capital city – Adelaide
Tasmania
North West Regional Hospital
Regional – Burnie
Launceston General Hospital
Regional – Launceston
Mersey Community Hospital
Regional – Latrobe
Royal Hobart Hospital
Capital city – Hobart
Victoria
68
The Alfred Hospital
Capital city – Melbourne – Prahran
Austin Health
Capital city – Melbourne – Heidelberg
Ballarat Health Services
Regional – Ballarat
Ballarat Oncology and Haematology Services
Regional – Wendouree
The Bendigo Hospital
Regional – Bendigo
Border Medical Oncology
Regional – Wodonga
Box Hill Hospital
Capital city – Melbourne – Box Hill
Breast Unit @ Mercy Private
Capital city – Melbourne – East Melbourne
Cabrini Hospital
Capital city – Melbourne – Malvern
Epworth Richmond Hospital
Capital city – Melbourne – Richmond
Frankston Hospital
Regional – Frankston
Frankston Private
Regional – Frankston
The Geelong Hospital
Regional – Geelong
Maroondah Hospital
Capital city – Melbourne – Maroondah
Monash Breast Clinic
Capital city – Melbourne – Clayton
Monash Medical Centre
Capital city – Melbourne – East Bentleigh
Peter MacCallum Cancer Centre
Capital city – Melbourne – East Melbourne
The Royal Melbourne Hospital
Capital city – Melbourne – Parkville
Capital city – Melbourne – Fitzroy
Western Hospital
Capital city – Melbourne – Footscray
Western Australia
Mount Hospital
Capital city – Perth
Royal Perth Hospital
Capital city – Perth
St John of God Hospital
Regional – Bunbury
Capital city – Perth – Subiaco
Sir Charles Gairdner Hospital
Capital city – Perth – Nedlands
New Zealand
Auckland City Hospital
City – Auckland
Christchurch Hospital
Regional – Christchurch
Dunedin Hospital
Regional – Dunedin
North Shore Hospital
City – Auckland
Palmerston North Hospital
Regional – Palmerston North
Waikato Hospital
Regional – Hamilton
Wellington Hospital
Capital city – Wellington – Wellington South
69
Group Members
Breast Physicians
Brennan, Meagan
Westmead Hospital
Chen, Juliana
NSW Breast Cancer Institute
Elder, Elisabeth
Fox, Jane
Freese, Sonja
Gilbert, Linda
Waikato Hospital
Godbolt, Patricia
Humeniuk, Vladimir
Lee, Naomi
The Breast Centre
Leong, Su-Lin
Mann, Lynne
Auburn Hospital
Masters, Richard
Box Hill Hospital
Read, Katrina
Sardelic, Frank
Snook, Kylie
North Shore Medical Centre
Spellman, Louise
Waikato Hospital
Stoney, David
Maroondah Hospital
Wei Leng Ooi, Corinne Moorabbin Hospital
Westmead
Westmead
Westmead
Bentleigh
Auckland
Hamilton
Taringa
Woodville
Gateshead
Westmead
Auburn
Box Hill
Melbourne
Tamworth
St Leonards
Hamilton
Ringwood
Bentleigh NSW
NSW
NSW
VIC
NEW ZEALAND
NEW ZEALAND
QLD
SA
NSW
NSW
NSW
VIC
VIC
NSW
NSW
NEW ZEALAND
VIC
VIC
Nedlands
Newcastle
Nedlands
Newcastle
Perth
St Leonards
Bunbury
Heidelberg
Wellington
Newcastle
Camperdown
Bentleigh
Auckland
Randwick
Port Macquarie
Bunbury
Hamilton
Tamworth
Merewether
Tweed Heads
Tweed Heads
Nambour
Nedlands
Latrobe
Herston
Newcastle
Darlinghurst
Coffs Harbour
Sydney
WA
NSW
WA
NSW
WA
NSW
WA
VIC
NEW ZEALAND
NSW
NSW
VIC
NEW ZEALAND
NSW
NSW
WA
NEW ZEALAND
NSW
NSW
NSW
NSW
QLD
WA
TAS
QLD
NSW
NSW
NSW
NSW
Study Coordinators / Research Nurses
Anderson, Robyn
Badger, Heath
Bailey, Cindy
Baker, Ann
Balgobin, Trina
Banks, Clare
Barry, Helen
Berger, Francesca
Bowers, Jayne
Boyes, Lauren
Bracken, Karen
Bradbury, Jo
Brown, Anna
Buchanan, Daisy
Buckley, Kiran
Carvalho, Sandra
Cavanagh, Shelley
Chamen, Margaret
Charlton, Julie
Chorlton, Charmayne
Clark, Sharon
Cocks, Chris
Cox, Lynette
Craigie, Heather
Cubitt, Annette
Dafo, Melissa
Dalley, Dale
Daly, Michelle
Dash, Denise
70
ANZBCTG
Newcastle Private Hospital
Austin Health
Wellington Hospital ANZBCTG
NHMRC Clinical Trials Centre
Monash Medical School
Port Macquarie Base Hospital St John of God Hospital
Waikato Hospital
Tamworth Rural Referral Hospital Lingard Private Hospital
The Tweed Hospital
The Tweed Hospital
Nambour Hospital
Mersey Community Hospital
Mater Hospital
D’Aulerio, Giuliana
Davis, Isabel
Deacon, Haley
Dean, Sally
Dempsey, Annette
Dhillon, Haryana
Dryden, Julie
Dwyer, Miriam
Dwyer, Gail
Earley, Amanda
Edhouse, Pam
Ellis, Lisa
Fettell, Suzzanna
Ficatas, Helen
Fong, Akiko
Free, Sue
French, Rowan
Freriechs, Cassie
Giddins, Suzanne
Goikhman, Albert
Goss, Carmel
Griffiths, Rebecca
Grundy, Renae
Hague, Wendy
Hammer, Elizabeth
Hampson, Su-Ann
Hansen, Belinda
Harrower, Yvonne
Healey, Danielle
Henderson, Kelly
Hobson, Christopher
Holt, Jane
Hoogeveen, Gillian
Hoque, Mafizul
Houghton, Sue
Howarth, Gabrielle
Howell, Deb
Howells, Caroline
Humm, Gillian
Hurford, Melanie
Innes-Rowe, Judy
Iywan, Rajani
Jackson, Elise
Jobling, Judy
Johns, Angela
Jolly, Lynne
Jones, Jeremy
Jongerden, Amy
Joppa, Barbara
Kelly, Kris
Ko, Sarah
Kong, Jing
Kumar, Sarandar
Lamoury, Gillian
Laycock, Ingrid
Cancer Council Clinical Trials
ANZBCTG
Hunter New England Area Health Service
ANZBCTG
The University of Sydney
Maroondah Hospital
HOCA Research Centre
Box Hill Hospital
ANZBCTG
Waikato Hospital
The Tweed Hospital
Box Hill Hospital
Frankston Hospital
ANZBCTG
Waikato Hospital
Bankstown-Lidcombe Hospital
The Alfred Hospital
The Cancer Council Victoria
The Tweed Hospital
The Northern Hospital
Centenary Institute
ANZBCTG
ANZBCTG
ANZBCTG
The Breast Centre
Manning Rural Referral Hospital
ANZBCTG
Nedlands
Bowral
Newcastle
Waratah
Newcastle
Sydney
Ringwood
Milton
Campbelltown
Herston
St Leonards
Bowral
Port Macquarie
Box Hill
Newcastle
Wodonga
Hamilton
Tweed Heads
Box Hill
Frankston
Ballarat
Tamworth
Hobart
Camperdown
Hobart
Ballarat
Newcastle
Newcastle
Melbourne
Hamilton
Coffs Harbour
Milton
Parkville
Bankstown
Melbourne
Nedlands
Carlton
Tweed Heads
Palmerston
Launceston
Nedlands
Epping
Camperdown
Newcastle
Newcastle
Darlinghurst
Kingswood
Newcastle
Auckland
Gateshead
Auckland
Randwick
Taree
St Leonards
Newcastle
WA
NSW
NSW
NSW
NSW
NSW
VIC
QLD
NSW
QLD
NSW
NSW
NSW
VIC
NSW
VIC
NEW ZEALAND
NSW
VIC
VIC
VIC
NSW
TAS
NSW
TAS
VIC
NSW
NSW
VIC
NEW ZEALAND
NSW
QLD
VIC
NSW
VIC
WA
VIC
NSW
NEW ZEALAND
TAS
WA
VIC
NSW
NSW
NSW
NSW
NSW
NSW
NEW ZEALAND
NSW
NEW ZEALAND
NSW
NSW
NSW
NSW
71
Lim, Yen
Lindsay, Dianne
Long, Sarah
Lopez, Celeste
Lord, Sarah
Ly, Mai
Macnab, Lauren
Maliepaard, Sharon
Martin, Jenepher
Mavin, Carlie
May, Jennifer
McCaffrey, Elizabeth
McCourt, Junie
McCoy, Melanie
McGowan, Eileen
Mellor, Dan
Metcalfe, Debbie
Moder, Rebecca
Morrison, Anthony
Moscovis, Sophia
Murray, Bronwyn
Neave, Lorraine
Newton, Alison
Ngu, Lily
Nguyen, Rose
Oleksyn, Katie
Oliver, Lesley
O’Neill, Christine
Ooi, William
Ouriques, Mayra
Paksec, Lisa
Pasanen, Leeanne
Pearson, Joanne
Petersen, Jennifer
Plenge, Patricia
Pollard, Elizabeth
Porten, Lauren
Power, Ann-Marie
Preston, Cecelia
Probert, Flonda
Quaggiotto, Melissa
Quarmby, Emma
Rajandran, Hema
Ranieri, Nadia
Rapson, Danielle
Raymond, Bronwyn
Reeves, Stuart
Richards, Kate
Rine, Cheryl
Ritchie, Hollie
Roberts, Pamela
Scarlet, Jenni
Scher, Barbara
Schmidt, Kristy
Scott, Karen
72
ANZBCTG
King Edward Memorial Hospital
ANZBCTG
ANZBCTG
Frankston Hospital
Box Hill Hospital
ANZBCTG
The Canberra Hospital
Signal Transduction Group
Waikato Hospital
ANZBCTG
ANZBCTG
ANZBCTG
ANZBCTG
ANZBCTG
ANZBCTG
The Breast Centre
ANZBCTG
The Cancer Council Victoria
Nambour Hospital
ANZBCTG
Hobart Private Hospital
Box Hill Hospital
ANZBCTG
Cabrini Hospital
ANZBCTG
Armidale Hospital
Waikato Hospital
Cabrini Hospital
ANZBCTG
The Alfred Hospital
Camperdown
Newcastle
Subiaco
Nedlands
Camperdown
Newcastle
Newcastle
Frankston
Box Hill
Newcastle
Woden
Woolloongabba
Kingswood
Nedlands
Camperdown
Melbourne
Hamilton
Newcastle
Newcastle
Newcastle
Camperdown
Auckland
Newcastle
Nedlands
Newcastle
Newcastle
Hobart
Gateshead
St Leonards
Randwick
Newcastle
Fitzroy
Bowral
Carlton
Darlinghurst
Nedlands
Auckland
Fitzroy
Nambour
Newcastle
Camperdown
Hobart
Nedlands
Fitzroy
Box Hill
St Leonards
Newcastle
Malvern
Port Macquarie
Newcastle
Armidale
Hamilton
Malvern
Newcastle
Melbourne
NSW
NSW
WA
WA
NSW
NSW
NSW
VIC
VIC
NSW
ACT
QLD
NSW
WA
NSW
VIC
NEW ZEALAND
NSW
NSW
NSW
NSW
NEW ZEALAND
NSW
WA
NSW
NSW
TAS
NSW
NSW
NSW
NSW
VIC
NSW
VIC
NSW
WA
NEW ZEALAND
VIC
QLD
NSW
NSW
TAS
WA
VIC
VIC
NSW
NSW
VIC
NSW
NSW
NSW
NEW ZEALAND
VIC
NSW
VIC
Scott, Rodney
Sheather, Kimberley
Sherman, Peter
Silcock, Judith
Smith, Jessica
Smith, Joanne
Smith, Robin
Sproule, Victoria
Stoneley, Adam
Suffolk, Jennifer
Taubman, Kristy
Teriana, Nory
Thomas, Rosemary
Thomas, Wendy
Thompson, Kerin
Thornton, Rochelle
Tipene, Marita
Tracey, Lauren
Trend, Stephanie
Vachan, Burcu
Wakefield, Matthew
Ward, Angie
Watson, Coralie
Watts, Kathryn
Webb, Julianne
Wegener, Vicky
Wellington, Karen
Whatman, Anne
Whitney, Sue
Wilkinson, Lisa
Wilks, Anne
Williams, Philippa
Winter, Rosemary
Withers, Emma
Wong, Shuet
Wood, Janice
Woolett, Anne
The University of Newcastle
Mater Hospital
The Breast Centre
ANZBCTG
The Alfred Hospital
ANZBCTG
Waikato Hospital
ANZBCTG
ANZBCTG
ANZBCTG
Mater Hospital
ANZBCTG
Westmead Hospital
Western Hospital
North West Regional Hospital
Callaghan
Sydney
Parkville
Gateshead
Newcastle
Coffs Harbour
Melbourne
Newcastle
Woolloongabba
Woolloongabba
Newcastle
Camperdown
Parkville
Hamilton
Auckland
Newcastle
Kingswood
Nedlands
Nedlands
Camperdown
Parkville
Newcastle
Newcastle
Sydney
Newcastle
Westmead
Bendigo
Campbelltown
Lismore
Footscray
Burnie
Port Macquarie
Westmead
Fitzroy
Bankstown
Auckland
Geelong
NSW
NSW
VIC
NSW
NSW
NSW
VIC
NSW
QLD
QLD
NSW
NSW
VIC
NEW ZEALAND
NEW ZEALAND
NSW
NSW
WA
WA
NSW
VIC
NSW
NSW
NSW
NSW
NSW
VIC
NSW
NSW
VIC
TAS
NSW
NSW
VIC
NSW
NEW ZEALAND
VIC
Tweed Heads
Newcastle
Brisbane
Newcastle
Elizabeth Vale
Campbelltown
Palmerston
Malvern
Gosford
Bankstown
Woolloongabba
Parkville
Liverpool
Epping
St Leonards
Parkville
NSW
NSW
QLD
NSW
SA
NSW
NEW ZEALAND
VIC
NSW
NSW
QLD
VIC
NSW
VIC
NSW
VIC
Medical Oncologists
Abdi, Ehtesham
Abell, Fiona
Abraham, Rick
Ackland, Stephen
Adams, Jacqui
Adams, Diana
Allan, Simon
Antill, Yoland
Aroney, Rodney
Asghari, Ray
Atkinson, Victoria
Bae, Susie
Bagia, Mamta
Barnett, Frances
Baron-Hay, Sally
Basser, Russell
The Tweed Hospital
Brisbane Private Hospital
Lyell McEwin Hospital
Cabrini Hospital
Gosford Hospital
Liverpool Hospital
The Northern Hospital
CSL Limited
73
Bastick, Patricia
St George Private Hospital
Bayliss, Evan
Beadle, Geoffrey
Wesley Medical Centre
Beale, Philip
Begbie, Stephen
Beith, Jane
Bell, David
Bell, Richard
Biddulph, Jane
Blum, Robert
Boadle, David
Bonaventura, Antonino Calvary Mater Newcastle
Bond, Rodney
Ballarat Medical Centre
Boyce, Adam
Boyle, Frances
Mater Hospital
Briscoe, Karen
Broom, Reuben
Buck, Martin
Bull, James
Burns, Ivon
Byard, Ian
Byrne, Michael
Chan, Arlene
Mount Hospital
Chantrill, Lorraine
Cheong, Kerry
Chern, Boris
Redcliffe Hospital
Chipman, Mitchell
Chirgwin, Jacquie
Maroondah Hospital
Clarke, Kerrie
Coates, Alan
IBCSG
Colosimo, Maree
Holy Spirit Northside Hospital
Craft, Paul
Cronk, Michelle
Nambour Hospital
Cuff, Katharine
Dalley, David
Davis, Alison
Day, Fiona
de Boer, Richard
Western Hospital
Dear, Rachel
University of Sydney
Della-Fiorentina, Stephen Macarthur Cancer Therapy Centre
deSouza, Paul
St George Hospital
Dewar, Joanna
Dowling, Anthony
Dunlop, Tracey
St George Hospital
Durrant, Simon
Edwards, James
Wellington Hospital
Eek, Richard
Feeney, Kynan
Findlay, Michael
University of Auckland
Fitzharris, Bernie
Foo, Serene
Austin Health
Forgeson, Garry
Francis, Heather
Ballarat Base Hospital
Francis, Prue
Friedlander, Michael
74
Kogarah
Perth
Auchenflower
Concord
Port Macquarie
Camperdown
St Leonards
Geelong
Auckland
Bendigo
Hobart
Waratah
Ballarat
Lismore
Sydney
Coffs Harbour
Auckland
Bunbury
Lismore
Fitzroy
Hobart
Gidgegannup
Perth
Campbelltown
Kurralta Park
Redcliffe
Melbourne
Ringwood
Wodonga
Centennial Park
Chermside
Woden
Nambour
Woolloongabba
Darlinghurst
Woden
Melbourne
Footscray
Sydney
Campbelltown
Kogarah
Nedlands
Fitzroy
Kogarah
Herston
Wellington
Wodonga
Nedlands
Auckland
Christchurch
Heidelberg
Palmerston
Ballarat
Melbourne
Randwick
NSW
WA
QLD
NSW
NSW
NSW
NSW
VIC
NEW ZEALAND
VIC
TAS
NSW
VIC
NSW
NSW
NSW
NEW ZEALAND
WA
NSW
VIC
TAS
WA
WA
NSW
SA
QLD
VIC
VIC
VIC
NSW
QLD
ACT
QLD
QLD
NSW
ACT
VIC
VIC
NSW
NSW
NSW
WA
VIC
NSW
QLD
NEW ZEALAND
VIC
WA
NEW ZEALAND
NEW ZEALAND
VIC
NEW ZEALAND
VIC
VIC
NSW
Ganju, Vinod
George, Mathew
Goggin, Leigh
Goldrick, Amanda
Goldstein, David
Gorddard, Nicole
Goss, Geraldine
Green, Michael
Grimes, David
Grimison, Peter
Grossi, Marisa
Grygiel, John
Hamilton, Kate
Hamilton, Anne
Harnett, Paul
Harris, Marion
Harrup, Rosemary
Harvey, Vernon
Hawson, Geoffrey
Haydon, Andrew
Heller, Wolfgang
High, Hilda
Hill, Jane
Holmes, Romayne
Hovey, Elizabeth
Inglis, Po-ling
Isaacs, Richard
Jameson, Michael
Jeffery, Mark
Jennens, Ross
Joshi, Abhishek
Joshi, Rohit
Joubert, Warren
Kannourakis, George
Karanth, Narayan
Karapetis, Christos
Kefford, Richard
Kennedy, Ian
Khasraw, Mustafa
Kiberu, Andrew
Kichenadasse, Ganessan
Kiely, Belinda
Kirsten, Fred
Koczwara, Bogda
Kotasek, Dusan
Kuper-Hommel, Marion
Lee, Chee
Lewis, Craig
Lindeman, Geoffrey
Loi, Sherene
Lombard, Janine
Long, Georgina
Lowenthal, Ray
Lynch, Jodi
Mainwaring, Paul
Malden, Trevor
Frankston Private Tamworth Rural Referral Hospital
Liverpool Hospital
Maroondah Hospital The Royal Melbourne Hospital
HOCA @ Wesley
Peter MacCallum Cancer Centre Westmead Hospital
Nambour Hospital
The Alfred Hospital
The Alfred Hospital
Waikato Hospital
Epworth Hospital
Cairns Base Hospital
Ballarat Oncology and Haematology Services
Royal Darwin Hospital
Westmead Hospital
Waikato Hospital
Waikato Hospital
Breast International Group
St George Hospital
St Andrew’s Medical Centre
Frankston
Tamworth
Nedlands
Liverpool
Randwick
Woden
Ringwood
Parkville
Milton
Camperdown
Melbourne
Darlinghurst
Ballarat
Melbourne Westmead
Bentleigh
Hobart
Auckland
Nambour
Melbourne
Launceston
Camperdown
Wagga Wagga
Melbourne
Randwick
Herston
Palmerston
Hamilton
Christchurch
Melbourne
Cairns
Adelaide
Woolloongabba
Ballarat
Tiwi
Bedford Park
Westmead
Hamilton
Geelong
Bunbury
Bedford Park
Camperdown
Bankstown
Bedford Park
Kurralta Park
Hamilton
Camperdown
Randwick
Parkville
Brussels
Newcastle
Camperdown
Hobart
Kogarah
Brisbane
Adelaide
VIC
NSW
WA
NSW
NSW
ACT
VIC
VIC
QLD
NSW
VIC
NSW
VIC
VIC
NSW
VIC
TAS
NEW ZEALAND
QLD
VIC
TAS
NSW
NSW
VIC
NSW
QLD
NEW ZEALAND
NEW ZEALAND
NEW ZEALAND
VIC
QLD
SA
QLD
VIC
NT
SA
NSW
NEW ZEALAND
VIC
WA
SA
NSW
NSW
SA
SA
NEW ZEALAND
NSW
NSW
VIC
Belgium
NSW
NSW
TAS
NSW
QLD
SA
75
Mallesara, Girish
Martin, David
Marx, Gavin
McCarthy, Nicole
McCrystal, Michael
McLachlan, Sue-Anne
McLaren, Blair
McLennan, Roger
McNeil, Catriona
Mileshkin, Linda
Millward, Michael
Mitchell, Gillian
Moon, Sarah
Moylan, Eugene
Murray, Nick
Ng, Siobhan
Nottage, Michelle
Nowak, Anna
Olesen, Inger
Olver, Ian
Patterson, Kevin
Pavlakis, Nick
Perez, David
Phillips, Kelly-Anne
Pittman, Ken
Porter, David
Potasz, Nicole
Power, Jeremy
Ransom, David
Redfern, Andrew
Richardson, Gary
Robinson, Bridget
Rutovitz, Joseph
Sabesan, Sabe
Schwarz, Max
Scott, Clare
Segelov, Eva
Selva-Nayagam, Sid
Sewak, Sanjeev
Shannon, Catherine
Shannon, Jenny
Simes, John
Simpson, Andrew
Singh, Madhu
Snyder, Raymond
Stewart, Josephine
Stewart, John
Stockler, Martin
Strickland, Andrew
Sullivan, Anne
Tattersall, Martin
Taylor, Anne
Teo, Lee Na
Thompson, Paul
Thomson, Jacqui
76
The Breast Centre
The Tweed Hospital
Sydney Adventist Hospital
North Shore Hospital St Vincent’s Hospital
Dunedin Hospital
Westmead Hospital
Dunedin Hospital
Cork University Hospital
The Cancer Council Australia
Armidale Hospital
Dunedin Hospital
Frankston Hospital
Cabrini Hospital
Sydney Adventist Hospital
The Townsville Hospital
The Alfred Hospital
Walter and Eliza Hall Institute of Medical Research
Wellington Hospital The Geelong Hospital
Austin Health
Ballarat Base Hospital
Frankston Hospital
Gateshead
Tweed Heads
Wahroonga
Herston
Auckland
Fitzroy
Dunedin
Geelong
Westmead
Melbourne
Nedlands
Melbourne
Dunedin
Cork
Adelaide
Subiaco
Herston
Nedlands
Hobart
Sydney
Woodville
Armidale
Dunedin
Melbourne
Woodville
Auckland
Frankston
Launceston
Subiaco
Perth
Malvern
Christchurch
Wahroonga
Douglas
Melbourne
Parkville
Darlinghurst
Adelaide
Geelong
Brisbane
Kingswood
Camperdown
Wellington
Geelong
Fitzroy
Heidelberg
Newcastle
Camperdown
Bentleigh
Concord
Sydney
Adelaide
Ballarat
Auckland
Frankston
NSW
NSW
NSW
QLD
NEW ZEALAND
VIC
NEW ZEALAND
VIC
NSW
VIC
WA
VIC
NEW ZEALAND
IRELAND
SA
WA
QLD
WA
TAS
NSW
SA
NSW
NEW ZEALAND
VIC
SA
NEW ZEALAND
VIC
TAS
WA
WA
VIC
NEW ZEALAND
NSW
QLD
VIC
VIC
NSW
SA
VIC
QLD
NSW
NSW
NEW ZEALAND
VIC
VIC
VIC
NSW
NSW
VIC
NSW
NSW
SA
VIC
NEW ZEALAND
VIC
Toner, Guy
Tsoi, Daphne
Underhill, Craig
van der Westhuizen, Andre
Van Hazel, Guy
Vasey, Paul
Walpole, Euan
Ward, Robyn
Webb, Suzanne
White, Shane
White, Michelle
Wilcken, Nicholas
Wong, Karmen
Woodward, Natasha
Wyld, David
Young, Rosemary
Melbourne
Nedlands
Wodonga
Newcastle
Nedlands
Auchenflower
Woolloongabba
Randwick
Cairns Base Hospital
Cairns
Austin Health
Heidelberg
Bentleigh
Westmead Hospital
Westmead
Gleneagles Medical Centre
Woolloongabba
Herston
Hobart
Non Clinical Participants
VIC
WA
VIC
NSW
WA
QLD
QLD
NSW
QLD
VIC
VIC
NSW
SINGAPORE
QLD
QLD
TAS
Bryce, Jennifer
Camberwell
Callaghan, Julie
Newcastle
Adamstown Heights
Carmichael, Wendy
Carpenter, Tamar
Newcastle
Conrad, Melinda
Private Consultancy
Mosman
Cranch, Joanne
Charlestown
Cummins, Anna
Newcastle
Douglass, Donna
ANZBCTG
Newcastle
Fewster, Sheryl
Perth
Finch, Karen
Leanyer
Forbes, Jenny
Hunter Breast Screen
Newcastle
Francis, Nicole
ANZBCTG
Newcastle
Frank, Sharyn
ANZBCTG
Newcastle
Garner, Helen
ANZBCTG
Newcastle
Gasson, Kellie
ANZBCTG
Newcastle
Goodenough, Rosemary
Grant, Cheryl
Denistone
Grantham, Glennice
Marion
Hainsworth, Leigh
Newcastle
Hamar, Michael
Sydney
Hunter, Linda
ANZBCTG
Newcastle
Jameson, Juliette
ANZBCTG
Newcastle
Kilmurray, Janice
Port Macquarie
Leggett, Jenny
Newcastle
Martin, Kelly
Newcastle
Moore, Janet
Milton
Porges, Stephen
Sydney
Preece, Debbie
Cardiff Heights
Raschke, Nicole
Port Macquarie
Reaby, Linda
Belconnen
Seccombe, Margaret
Valentine
Sipple, Lisa
ANZBCTG
Newcastle
Smith, Allan
Sydney
Vullo, Katie
ANZBCTG
Newcastle
Wasik, Christine
ANZBCTG
Newcastle
Palmerston North
Whitehead, Eleanor
Whiteside, Carol
Perth
VIC
NSW
NSW
NSW
NSW
NSW
NSW
NSW
WA
NT
NSW
NSW
NSW
NSW
NSW
NSW
NSW
SA
NSW
NSW
NSW
NSW
NSW
NSW
NSW
QLD
NSW
NSW
NSW
ACT
NSW
NSW
NSW
NSW
NSW
NEW ZEALAND
WA
77
Wilks, Stacey
ANZBCTG
Worgan, Toni
Young, Leonie
Newcastle
Maryville
Sunnybank
NSW
NSW
QLD
Newcastle
Auchenflower
NSW
QLD
The University of Queensland
The University of Melbourne
Walter and Eliza Hall Institute of Medical Research
Sydney
Herston
Sydney
Sydney
Fitzroy
Parkville
NSW
QLD
NSW
NSW
VIC
VIC
Monash Medical School
Private Practice
Bentleigh
Melbourne
VIC
VIC
Westmead Hospital
Westmead
NSW
Cotton Tree Specialist Centre
Maroochydore
QLD
Melbourne Pathology
Melbourne Pathology
The University of Queensland
Garvan Institute of Medical Research
Collingwood
Collingwood
Auckland
Woolloongabba
Herston
Darlinghurst
Darlinghurst
Darlinghurst
VIC
VIC
NEW ZEALAND
QLD
QLD
NSW
NSW
NSW
Westmead
Hamilton
Christchurch
Auckland
Bendigo
Frankston
Adelaide
Brisbane
Auchenflower
Launceston
Camperdown
Melbourne
Liverpool
Port Macquarie
Melbourne
NSW
NEW ZEALAND
NEW ZEALAND
NEW ZEALAND
VIC
VIC
SA
QLD
QLD
TAS
NSW
VIC
NSW
NSW
VIC
Nurse Counsellors Hussain, Carole
McColl, Sonya
Hunter Breast Screen
Wesley Research Institute
Clinical Researchers
Butow, Phyllis
Eakin, Elizabeth
Juraskova, Ilona
King, Madeleine
Thompson, Erik
Visvader, Jane
Endocrinologists
Davis, Susan
Stern, Cathryn
Geneticists
Kirk, Judy
Haematologists
Kellner, Sybil
Pathologists
Brown, Robert
Constable, Leonie
Craik, Jan
Francis, Glenn
Lakhani, Sunil
Millar, Ewan
O’Toole, Sandra
Sutherland, Robert
Radiation Oncologists
Ahern, Verity
Angell, Ruth
Atkinson, Christopher
Benjamin, Chellaraj
Bishop, Michelle
Blakey, David
Borg, Martin
Bryant, Guy
Burke, Marie-Frances
Byram, David
Carroll, Susan
Chua, Boon
Delaney, Geoff
Donovan, Jenny
Drummond, Roslyn
78
Westmead Hospital
Waikato Hospital
Frankston Radiation
Wesley Cancer Care Centre
Liverpool Hospital
Francis, Michael
Gauden, Stan
Graham, Peter
Harvey, Jennifer
Jacob, George
Johnson, Carol
Joseph, David
Kenny, Lizbeth
Leong, Eugene
Lonergan, Denise
Matthews, John
Peres, Helen
Phillips, Claire
Pitson, Graham
Round, Glenys
Stevens, Mark
Taylor, Karen
Walker, Quenten
Wang, Tim
Wynne, Chris
Zissiadis, Yvonne
St George Hospital
Mater Queensland Radium Institute
Wellington Hospital
ANZBCTG
East Coast Cancer Centre
Regional Cancer Centre
The Alfred Hospital
Westmead Hospital
Perth Radiation Oncology Group
Geelong
Launceston
Kogarah
Brisbane
Woden
Wellington
Nedlands
Herston
Newcastle
Campbelltown
Port Macquarie
Brisbane
Melbourne
Geelong
Hamilton
Wagga Wagga
Melbourne
Wagga Wagga
Westmead
Christchurch
Wembley
VIC
TAS
NSW
QLD
ACT
NEW ZEALAND
WA
QLD
NSW
NSW
NSW
QLD
VIC
VIC
NEW ZEALAND
NSW
VIC
NSW
NSW
NEW ZEALAND
WA
Lakeview Imaging
Nambour Hospital
Middlemore Hospital
Warana
Nambour
Auckland
Auckland
QLD
QLD
NEW ZEALAND
NEW ZEALAND
Camperdown
Newcastle
Ryde
Camperdown
Camperdown
NSW
NSW
NSW
NSW
NSW
Camperdown
Gateshead
Hamilton
Gateshead
Hamilton
Brisbane
Strathfield
Auckland
Bentleigh
Auckland
Auckland
Westmead
Brisbane
Gosford
Ringwood
Wagga Wagga
Camperdown
St Leonards
NSW
NSW
NEW ZEALAND
NSW
NEW ZEALAND
QLD
NSW
NEW ZEALAND
VIC
NEW ZEALAND
NEW ZEALAND
NSW
QLD
NSW
VIC
NSW
NSW
NSW
Radiologists
Paszkowski, Andrew
Pfeiffer, Deborah
Urry, Sally
Whitlock, Jeremy
Statistician / Computer Scientists
Gebski, Val
Green, Andrew
Hudson, Malcolm
Veillard, Anne-Sophie
Zannino, Diana
ANZBCTG
Macquarie University
Breast Surgeons
Carmalt, Hugh
Clark, David
The Breast Centre
Creighton, Jane
Waikato Hospital
Douglas, Charles
The Breast Centre
Ehrstrom, Marcus
Waikato Hospital
Fryar, Barry
Gluch, Laurence
The Strathfield Breast Centre
Harman, Richard
Hart, Stewart
Juhasz, Eva
Kelly, Erica
Krishnan, Sandra
Westmead Hospital
Lambley, Jason
Laura, Sharon
Private Practice
Law, Michael
Maroondah Breast Clinic
Littlejohn, David
Private Practice
Mak, Cindy
Moore, Katrina
79
O’Brien, Jane
O’Donoghue, Gerrard
Pitcher, Meron
Sacks, Nigel
Scott, Belinda
Speakman, David
Tasevski, Robert
Thomson, David
Walker, Melanie
Walsh, David
Western Hospital
Lyell McEwin Hospital
Breast Associates Ltd
Monash Breast Clinic
Melbourne
Parkville
Footscray
Elizabeth Vale
Auckland
Port Macquarie
Parkville
Randwick
Clayton
Woodville
VIC
VIC
VIC
SA
NEW ZEALAND
VIC
VIC
NSW
VIC
SA
The Royal Melbourne Hospital Parkville
VIC
Austin Hospital
Melbourne
Glen Iris
VIC
VIC
Clinical Fellow / Surgeon
Skandarajah, Anita
Clinical Fellow
Harvey, Sandra
Yeung, Yvonne
Consultant Surgeon Donnelly, Peter
Ward, Malcolm
Torbay Hospital
Christchurch
UNITED KINGDOM
NEW ZEALAND
The Specialist Centre
Nambour Hospital
Medical Centre
Private Practice
Private Practice
Ballarat
Auckland
Nambour
Cabramatta
Newcastle
Camden
Coffs Harbour
Bankstown
Campbelltown
VIC
NEW ZEALAND
QLD
NSW
NSW
NSW
NSW
NSW
NSW
Melbourne
Woolloongabba
Bedford Park
Liverpool
Hamilton
Heidelberg
Mildura
Parkville
Nambour
Lismore
Nambour
Nambour
Melbourne
Newcastle
Lismore
Westmead
Melbourne
Adelaide
Strathfield
VIC
QLD
SA
NSW
NEW ZEALAND
VIC
VIC
VIC
QLD
NSW
QLD
QLD
VIC
NSW
NSW
NSW
VIC
SA
NSW
General Surgeons
Bollard, Ruth
Gerred, Susan
Grieve, David
Lee, Richard
Levy, Richard
Lim, Edwin
Ross, William
Soon, Patsy
Stewart, Katherine
Surgical Oncologists
Baker, Caroline
Bennett, Ian
Birrell, Stephen
Bonar, Tom
Liverpool Hospital
Campbell, Ian
Waikato Hospital
Castles, Lindsay
Austin Health
Chambers, Kevin
Bendigo Hospital
Collins, John
Creighton, Lisa
Nambour Hospital
Curtin, Austin
Darcy, Justin
Nambour Hospital
Donovan, Michael
Nambour Hospital
Efe, Narine
Freemasons Medical Centre
Forbes, John
Foster, Hamish
French, James
Westmead Hospital
Gale, Timothy
Gill, Peter Grantley
Gillett, David
The Strathfield Breast Centre
80
Gregory, Peter
Hargreaves, Warren
Hastrich, Diana
Mount Hospital
Henderson, Michael
Hughes, Malcolm
Hughes, Thomas
SAN Clinic
Hyams, David
Eisenhower Medical Centre
Jones, Wayne
Kay, Ron
Kitchen, Paul
Kling, Neill
Mann, Bruce
Millar, Robert
Miller, Julie
Miller, Iain
Mitchell, Gregory
Molland, Gail
Castle Hill Day Surgery
Moon, Dominic
Westmead Hospital
Murphy, Craig
Neil, Suzanne
Ng, Alexander
Noushi, Farnoush
Cancer Institute of NSW
Oliver, David
Pyke, Christopher
Rice, Mark
Robertson, Robert
Private Practice
Saunders, Christobel
University Western Australia
Serpell, Jonathon
Cabrini Hospital
Shah, Aashit
Liverpool Hospital
Simon, Robert
Spillane, Andrew
Mater Hospital
Sywak, Mark
Townend, David
Ung, Owen
Wetzig, Neil
Wilkinson, Stephen
Hobart Private Hospital
Brighton
Darlinghurst
Perth
Melbourne
Port Macquarie
Wahroonga
Rancho Mirage
Auckland
Auckland
Fitzroy
Bunbury
Parkville
Parkville
Parkville
Sale
Geelong
Castle Hill
Westmead
Melbourne
Melbourne
Auckland
Lindfield
Murdoch
Brisbane
Dubbo
Christchurch
Perth
Malvern
Liverpool
Lismore
Sydney
St Leonards
Lismore
Westmead
Auchenflower
Hobart
VIC
NSW
WA
VIC
NSW
NSW
USA
NEW ZEALAND
NEW ZEALAND
VIC
WA
VIC
VIC
VIC
VIC
VIC
NSW
NSW
VIC
VIC
NEW ZEALAND
NSW
WA
QLD
NSW
NEW ZEALAND
WA
VIC
NSW
NSW
NSW
NSW
NSW
NSW
QLD
TAS
81
Funders and Supporters
Breast Cancer Research Foundation, USA
Cancer Australia
Cancer Institute NSW
Hunter Medical Research Institute
National Breast Cancer Foundation
National Health and Medical Research Council
NSW Department of Health
University of Newcastle
Sponsors
Corporate Sponsors
The Cartridge Recycler
Dateline Imports
2010 Avon race for research Sponsors (Major and Official)
Avon
Newcastle Permanent
Southern Cross Ten
The Herald
Radio Newcastle NXFM
NCP Printing
Instant Access
Cactus Creative Communications
Curves
82
Volunteers
2010 Avon Race for Research Volunteers
Mr Bob Adams
Ms Jenny Forbes
Ms Halina Paczynski
Ms Jenny Beldham
Ms Helen Gali
Mr Barry Pearson
Mr Kevin Burbridge
Mr Andy Girtchen
Ms Lyn Pearson
Mr Michael Burke
Ms Mavis Godber
Ms Ashlea Raper
Ms Kirrilee Cawthorne
Mr Andrew Green
Mr Tony Raper
Mr Jim Cowburn
Mr Bob Grey
Mr Chris Regent
Mr Paul Cranch
Ms Emma Hetherington
Mr Mike Ritchie
Ms Leah Cummins
Ms Carole Hussain
Ms Gaylene Rowe
Ms Melissa Dafo
Ms Bridie Ingham
Mr John Scanlon
Mr Peter Dall
Ms Cathy Ingham
Ms Lyn Scanlon
Mr Derek Davelaar
Mr Neil Ingham
Ms Karolyn Scott
Ms Caroline Davies
Ms Marion Jones
Ms Anita Slade
Mr Trevor Davies
Mr Chris Leggett
Mr Dennis Slade
Ms Marea Davoren
Mr Andrew Lucas
Mr Philip Sorensen
Ms Marilyn Donn
Mr Ron McLeod
Ms Maureen Tait
Mr John Donn
Mr Anthony Martin
Mr Rob Tickner
Ms Ruth Douglass
Ms Chris Millett
Ms Nerida Walker
Ms Jenny Dunne
Mr Geoff Muldoon
Ms Cathy Walmsley
Ms Cate Dymond
Mr Mike Newton
Ms Maria Walz
Mr Alex Feeny
Mr Chris Nottle
Ms Jessie White
Mr Matt Ferrie
Mr Dave Pacey
■■
ANZBCTG and BCIA staff were also volunteers at this event.
83
84
Financial Report
The ANZBCTG is a not-for-profit, collaborative, national and international breast cancer clinical trials research
group. It is an independent registered company with academic affiliations.
The ANZBCTG is governed by a Board of Directors and the terms of its Constitution. The Board of
Directors has a Finance and Audit Subcommittee (FAC) to assist with its financial oversight responsibilities.
This Board subcommittee has a Terms of Reference and meets four times per year.
Financial management of the ANZBCTG has two main facets:
■■
management of ANZBCTG finances and resources (financial year – 1 April to 31 March);
■■
management of competitive and other grant funds administered by other Institutions.
Each year the ANZBCTG undergoes independent financial audit to ensure its compliance with all applicable
company, taxation, charitable and financial legislation and regulation. The ANZBCTG’s independent auditor
is rotated every five years and the current company auditor will provide audit services until the end of the
2013/2014 financial year.
Financial Management of the ANZBCTG
Because of its company status, the majority of the ANZBCTG’s income is managed directly by the Group.
The Chief Operating Officer undertakes day to day financial management according to the delegations vested
in this position by the Board, and ensures the ANZBCTG adheres to applicable Australian corporate, taxation
and charitable legislation.
Sources of ANZBCTG income:
■■
clinical trials research program (pharmaceutical partnerships, international collaborative group
partnerships, untied education grants, ANZBCTG Annual Scientific Meeting);
■■
competitive grants awarded to the ANZBCTG (Cancer Australia);
■■
fundraising income (donations, special events, corporate support);
■■
bequests;
■■
other income (Annual Scientific Meeting registration fees and sponsorship, sundry).
Areas of ANZBCTG expenditure:
■■
clinical trials research program (clinical trials development, activation, coordination and quality assurance
activities, funding for participating institutions, randomisation and statistical analyses, staff member
salaries, Annual Scientific Meeting and other meetings);
■■
fundraising;
■■
other recurrent monthly infrastructure costs, staff member salaries and core business expenses.
The ANZBCTG has implemented a prudent investment policy to manage its cash reserves and to ensure
appropriate returns on these reserves are realised. The investment policy adheres to all relevant legislative and
regulatory requirements for the investment of donated funds.
Financial Management of Competitive Grant Funds Administered by other Institutions
The ANZBCTG applies for and secures competitive grants. Competitive grant funding mechanisms include
streams for both research and infrastructure funding, and can be sourced from many organisations including
but not limited to:
85
■■
National Health and Medical Research Council (government);
■■
Cancer Institute NSW (government);
■■
Cancer Councils (government/private);
■■
National Breast Cancer Foundation (private);
■■
Other Trusts and Foundations.
Competitive grant funds are administered by a recognised ‘administering institution’ and it is the responsibility
of the administering institution to financially and legally account for the grants it administers. The University of
Newcastle is the ANZBCTG’s usual administering institution and competitive grant funding administered by
this or other institutions is not shown in the financial statements of the ANZBCTG.
During the reporting period the ANZBCTG held the following competitive grants administered by other
institutions:
■■
■■
Five NHMRC project grants supporting the following trials: IBIS-I, IBIS-II, LATER, SOFT and TEXT, and
Co-SOFT;
One Cancer Institute NSW infrastructure grant.
The Group’s competitive grant holdings amounted to just over $1.3 million for the reporting period.
Financial Statements
The statements contained in this Financial Report are a summary of the independently audited accounts for the
financial year ended 31 March 2011. Full audited financial statements are available by contacting the ANZBCTG.
Any ANZBCTG surplus is committed to supporting current and future ANZBCTG research projects.
All ANZBCTG payroll liabilities are annually expensed to the external suppliers which manage the ANZBCTG’s
payroll.
Income Statement
86
2011
$
2010
$
Revenues from ordinary activities
9,706,150
9,969,525
Clinical trials research program expenses
5,533,185
5,377,598
Donations and fundraising expenses
1,157,259
1,160,536
Other expenses
1,444,576
904,550
8,135,020
7,442,684
Net surplus from ordinary activities
1,571,130
2,526,841
Total changes in equity
1,571,130
2,526,841
Statement of Financial Position
2011
$
2010
$
CURRENT ASSETS
Cash assets
7,979,835
14,464,280
Receivables
1,817,993
1,835,170
Other financial assets
8,074,227
-
212,502
84,569
18,084,557
16,384,019
Other financial assets
100,817
121,163
Property, plant and equipment
331,933
374,420
Total non-current assets
432,750
495,583
18,517,307
16,879,602
Payables and other liabilities
2,776,575
2,710,000
Total current liabilities
2,776,575
2,710,000
TOTAL LIABILITIES
2,776,575
2,710,000
15,740,732
14,169,602
Accumulated funds
15,740,732
14,169,602
TOTAL ACCUMULATED FUNDS
15,740,732
14,169,602
Other assets
Total current assets
NON-CURRENT ASSETS
TOTAL ASSETS
CURRENT LIABILITIES
NET ASSETS
ACCUMULATED FUNDS
87
Summary Income and Expenditure Statement
2011
$
2010
$
Clinical trials research program
3,103,639
3,969,253
Donations and fundraising
4,649,570
4,720,725
Bequests
113,355
16,670
Cancer Australia infrastructure grant
861,439
361,875
Bank interest
696,680
405,836
Other
281,467
495,166
9,706,150
9,969,525
Clinical trials research program*
5,533,185
5,377,598
1,157,259
1,160,536
Other
1,444,576
904,550
TOTAL EXPENSES
8,135,020
7,442,684
NET SURPLUS
1,571,130
2,526,841
INCOME
TOTAL INCOME
EXPENDITURE
* See page 85 for further details.
88
Income
Bequests
Cancer Australia infrastructure grant
Interest
Other
Expenditure
Other
89
Statement of Cash Flows
2011
$
Inflow/(Outflow)
2010
$
Inflow/(Outflow)
8,918,150
10,546,172
696,680
405,836
(7,997,640)
(7,807,610)
1,617,190
3,144,398
CASH FLOWS FROM OPERATING ACTIVITIES
Receipts from customers, donors and external funding
Interest received
Payments to suppliers and employees
Net cash provided by (used in) operating activities
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment
(72,216)
(33,268)
Purchase of investments
(8,029,419)
-
Net cash by (used in) investing activities
(8,101,635)
(33,268)
Net increase/(decrease) in cash held
(6,484,445)
3,111,130
Cash at the beginning of the year
14,464,280
11,353,150
7,979,835
14,464,280
Cash at the end of the year
BCIA Fundraising Income and Expenditure Statement
2011
$
2010
$
2,285,263
2,443,476
647,034
684,464
1,638,229
1,759,011
Income
777,310
675,741
Expense
49,282
37,001
728,028
638,740
1,586,997
1,601,509
460,943
439,070
Net income
1,126,054
1,162,439
TOTAL INCOME
4,649,570
4,720,726
TOTAL EXPENDITURE
1,157,259
1,160,536
NET INCOME FROM FUNDRAISING
3,492,311
3,560,190
DONATIONS
Income
Expense
Net income
CORPORATE SUPPORT
Net income
SPECIAL EVENTS AND PROJECTS
Income
Expense
■■
90
This statement does not include Bequest Income ($113,355).
Publications
01/04/2010 to 31/12/2010
786.
Badger HD, Hunter LM, Chirgwin J, Forbes JF, Lindsay DF, Laycock I, Dempsey A. Strategies for
Participant Recruitment: The SOLE Initiative. COSA 2010;Poster 222.
787.
Buzdar A, Cuzick J, Sestak I, Howell A, Dowsett M, Baum M, Forbes JF, ATAC/LATTE
Investigators. Ten-year analysis of the ATAC trial. ASCO 2010;Abstract 256.
788.
Coleman RE, Banks LM, Girgis SI, Vrdoljak E, Fox J, Cawthorn SJ, Patel A, Bliss JM,
Coombes RC, Kilburn LS. Reversal of skeletal effects of endocrine treatments in the Intergroup
Exemestane Study. Breast Cancer Res Treat 2010;124(1):153-161.
789.
Colleoni M, Cole BF, Viale G, Regan MM, Price KN, Maiorano E, Mastropasqua MG, Crivellari D,
Gelber RD, Goldhirsch A, Coates AS, Gusterson BA. Classical cyclophosphamide, methotrexate,
and fluorouracil chemotherapy is more effective in triple-negative, node-negative breast cancer:
results from two randomized trials of adjuvant chemoendocrine therapy for node-negative breast
cancer. J Clin Oncol 2010;28(18):2966-2973.
790.
Colleoni M, Giobbie-Hurder A. Benefits and adverse effects of endocrine therapy.
Ann Oncol 2010;21(Suppl.7):vii107-vii111.
791.
Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF, on behalf of the
ATAC/LATTE investigators. Effect of anastrozole and tamoxifen as adjuvant treatment for earlystage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol 2010;11(12):1135-1141.
792.
Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M,
Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S. Prediction of risk of distant recurrence
using the 21-gene recurrence score in node-negative and node-positive postmenopausal
patients with breast cancer treated with anastrozole or tamoxifen: A TransATAC study.
J Clin Oncol 2010;28(11):1829-1834.
793.
Forbes JF. Overview and future perspectives of primary breast cancer. In: Toi M, Winer EP, eds.
Local and systemic management of primary breast cancers. Trans Pacific Press 2010;3-17.
794.
Forbes JF, Boyle F, Wilcken N, Lindsay DF, Leong E. Clinical Trials Open for Participant Entry.
COSA 2010;Poster 242.
795.
Goss PE, Ingle JN, Chapman J-AW, Ellis MJ, Sledge GW, Budd GT, Rabaglio M, Gelmon K,
Shepherd L, Pritchard KI. Final analysis of NCIC CTG MA.27: A randomized phase III trial of
exemestane versus anastrozole in postmenopausal women with hormone receptor positive primary
breast cancer. SABCS 2010;Abstract S1-1.
796.
Juraskova I, Butow P, Smith B, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF.
Improving informed consent: Evaluating the first decision aid in a clinical trial setting (IBIS-II breast
cancer prevention trial). SABCS 2010;Poster 901.
797.
Karlsson P, Cole BF, Colleoni M, Roncadin M, Chua BH, Murray E, Price KN,
Castiglione-Gertsch M, Goldhirsch A, Gruber G, for the International Breast Cancer Study
Group. Timing of radiotherapy and outcome in patients receiving adjuvant endocrine therapy.
Int J Rad Oncol Biol Phys 2010:E-pub 23 Aug 2010.
91
92
798.
Lee CK, Stockler MR, Coates AS, Gebski V, Lord SJ, Simes RJ on behalf of Australian New
Zealand Breast Cancer Trials Group. Self-reported health-related quality of life is an independent
predictor of chemotherapy treatment benefit and toxicity in women with advanced breast cancer.
Br J Cancer 2010;102(9):1341-1347.
799.
Leyland-Jones B, Regan MM, Bouzyk M, Kammler R, Tang W, Pagani O, Maibach R,
Dell’Orto P, Thürlimann B, Price KN, Viale G. Outcome according to CYP2D6 genotype among
postmenopausal women with endocrine-responsive early invasive breast cancer randomized in the
BIG 1-98 trial. SABCS 2010;Abstract S1-8.
800.
Maiorano E, Regan MM, Viale G, Mastropasqua MG, Colleoni M, Castiglione-Gertsch M,
Price KN, Gelber RD, Goldhirsch A, Coates AS. Prognostic and predictive impact of central
necrosis and fibrosis in early breast cancer: Results from two International Breast Cancer
Study Group randomized trials of chemoendocrine adjuvant therapy.
Breast Cancer Res Treat 2010;121:211-218.
801.
McCullough AE, Dell’Orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB,
Andrighetto S, Chen B, Lingle WL, Jackisch C, Perez EA, Piccart-Gebhart MJ, Viale G.
Concordance of HER2 central assessment by two international central laboratories: A ring study
within the framework of the adjuvant HER2-positive ALTTO trial (BIG 2-06/N063D/EGF106708).
SABCS 2010;Poster 1036.
802.
Paridaens RJ, Gelber S, Cole BF, Gelber RD, Thürlimann B, Price KN, Holmberg SB, Crivellari D,
Coates AS, Goldhirsch A. Adjuvant! Online estimation of chemotherapy effectiveness when
added to ovarian function suppression plus tamoxifen for premenopausal women with
estrogen-receptor-positive breast cancer. Breast Cancer Res Treat 2010;123(1):303-310.
803.
Partridge AH, Gelber S, Piccart M, Focant F, Scullion M, Holmes E, Winer E, Gelber R on behalf
of the HERA Trial Study Team. The effect of age on breast cancer outcomes in women with Her-2
positive breast cancer: results from the HERA trial. SABCS 2010;Poster 912.
804.
Phillips K-A, Ribi K, Sun Z, Stephens A, Thompson A, Harvey V, Thürlimann B, Cardoso F,
Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J. Cognitive function in
postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98
randomized trial. The Breast 2010;19(5):388-395.
805.
Pinder SE, Duggan C, Ellis IO, Cuzick J, Forbes JF, Bishop H, Fentiman IS, George WD, on behalf
of the UK Coordinating Committee on Cancer Research (UKCCCR) Ductal Carcinoma In Situ
(DCIS) Working Party. A new pathological system for grading DCIS with improved prediction of
local recurrence: results from the UKCCCR/ANZ DCIS trial. Br J Cancer 2010;103(1):94-100.
806.
Procter M, Suter TM, de Azambuja E, Dafni U, van Dooren V, Muehlbauer S, Climent MA,
Rechberger E, Liu WT-W, Toi M, Coombes RC, Dodwell D, Pagani O, Madrid J, Hall M,
Chen S-C, Focan C, Muschol M, van Veldhuisen DJ, Piccart-Gebhart MJ. Longer-term
assessment of trastuzumab-related cardiac adverse events in the herceptin adjuvant (HERA) trial.
J Clin Oncol 2010;28(21):3422-3428.
807.
Rabaglio M, Ruepp B, for the SOFT/TEXT/PERCHE Steering Committee. Death due to liver failure
during endocrine therapy for premenopausal breast cancer. Acta Oncol 2010;49:874-876.
808.
Rae JM, Drury S, Hayes DF, Stearns V, Thibert JN, Haynes BP, Salter J, Pineda S, Cuzick J,
Dowsett M. Lack of correlation between gene variants in tamoxifen metabolizing enzymes with
primary endpoints in the ATAC trial. SABCS 2010;Abstract S1-7.
809.
Ring A, Sestak I, Baum M, Howell A, Buzdar A, Dowsett M, Forbes JF, Cuzick J on behalf of
the LATTE Trialists’ Group. The influences of co-morbidities and age on risk of death without
recurrence: A retrospective analysis of the ATAC trial. SABCS 2010;Poster 1303.
810.
Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J. Effect of body mass index on
recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC
trial. J Clin Oncol 2010;28(21):3411-3415.
811.
Thornton R, Hunter LM, Ward A, Boyle F, Green M, Forbes JF. ANZ 0501 Later adjuvant
Aromatase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer
(LATER). COSA 2010;Poster 243.
812.
Zabaglo L, Stoss O, Rueschoff J, Zielinski D, Salter J, Bradbury I, Arfi M, Dafni U, Procter M,
Dowsett M for the HERA Trial Study Team. Impact of HER2 staining intensity on prognosis and
treatment benefit of adjuvant trastuzumab given after chemotherapy: the HERA trial experience.
SABCS 2010;Poster 1001.
813.
Zhang JJ and Wang M. Latent class joint model of ovarian function suppression and DFS for
premenopausal breast cancer patients. Stat Med 2010;29(22):2310-2324.
01/01/2011 to 31/03/2011
814.
Aebi S, Sun Z, Braun D, Price KN, Castiglione-Gertsch M, Rabaglio M, Gelber RD, Crivellari D,
Lindtner J, Snyder R, Karlsson P, Simoncini E, Gusterson BA, Viale G, Regan MM, Coates AS,
Goldhirsch A. Differential efficacy of three cycles of CMF followed by tamoxifen in patients with
ER-positive and ER-negative tumors: Long-term follow up on IBCSG Trial IX.
Ann Oncol 2011;E-pub 31 Jan 2011.
815.
Colleoni M, Giobbie-Hurder A, Regan MM, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF,
Paridaens R, Láng I, Smith I, Chirgwin J, Pienkowski T, Wardley A, Price KN, Gelber RD, Coates AS,
Goldhirsch A. Analyses adjusting for selective crossover show improved overall survival with adjuvant
letrozole compared with tamoxifen in the BIG 1-98 study. J Clin Oncol 2011;29(9):1117-1124.
816.
Cuzick J, DeCensi A, Arun B, Brown PH, Castiglione M, Dunn B, Forbes JF, Glaus A, Howell A,
von Minckwitz G, Vogal V, Zwierzina H. Preventive therapy for breast cancer: a consensus
statement. Lancet Oncol 2011;E-pub 28 March 2011.
817.
Cuzick J, Sestak I, Pinder SE, Ellis IO, Forsyth S, Bundred NJ, Forbes JF, Bishop H, Fentiman IS,
George WD. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma
in situ: long-term results from the UK/ANZ DCIS trial. Lancet Oncol 2011;12(1):21-29.
818.
Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I,
Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A,
Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI,
Piccart-Gebhart MJ, Bell R, for the Herceptin Adjuvant (HERA) Trial Study Team. Treatment with
trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast
cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol 2011;12(3):236-244.
819.
Karlsson P, Sun Z, Braun D, Price KN, Castiglione-Gertsch M, Rabaglio M, Gelber RD,
Crivellari D, Collins J, Murray E, Zaman K, Colleoni M, Gusterson BA, Viale G, Regan MM,
Coates AS, Goldhirsch A. Long-term results of International Breast Cancer Study Group
Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for
premenopausal patients with node-negative breast cancer. Ann Oncol 2011;E-pub 16 Feb 2011.
820.
Phillips K-A, Aldridge J, Ribi K, Sun Z, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O,
Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J. Cognitive function in postmenopausal
breast cancer patients one year after completing adjuvant endocrine therapy with letrozole and/or
tamoxifen in the BIG 1-98 trial. Breast Cancer Res Treat 2011;126(1):221-226.
821.
Phillips KA, Ribi K, Fisher R. Do aromatase inhibitors have adverse effects on cognitive function?
Breast Cancer Res 2011;13(1):203.
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caring–The relative impact of sharing decisions versus managing emotions on patient outcomes.
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823.
Valero V, Forbes J, Pegram MD, Pienkowski T, Eiermann W, von Minckwitz G, Roche H,
Martin M, Crown J, Mackey JR, Fumoleau P, Rolski J, Mrsic-Krmpotic Z, Jagiello-Gruszfeld A,
Riva A, Buyse M, Taupin H, Sauter G, Press MF, Slamon DJ. Multicenter phase III randomized trial
comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as
first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer
(BCIRG 007 study): Two highly active therapeutic regimens. J Clin Oncol 2011;29(2):149-156.
824.
Viale G, Regan MM, Dell’Orto P, Mastropasqua MG, Maiorano E, Rasmussen BB, MacGrogan G,
Forbes JF, Paridaens RJ, Colleoni M, Láng I, Thürlimann B, Mouridsen H, Mauriac L, Gelber RD,
Price KN, Goldhirsch A, Gusterson BA, Coates AS for the BIG 1-98 Collaborative and International
Breast Cancer Study Groups. Which patients benefit most from adjuvant aromatase inhibitors?
Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial.
Ann Oncol 2011;E-pub 18 Feb 2011.
Glossary of Terms
ACCRUAL TARGET (RECRUITMENT TARGET): The number of participants planned to be enrolled in the trial.
ADJUVANT THERAPY: Additional treatment used to improve the effects of surgical treatment. In cancer, adjuvant
therapy may include chemotherapy, hormonal or radiation therapy after surgery, which is aimed at killing any
remaining cancer cells.
ADVANCED BREAST CANCER: Cancer that has spread from the original site in the breast (metastasised) to other
organs or tissues in the body. Also known as secondary breast cancer or metastatic breast cancer.
ANGIOGENIC: Blood vessel formation, which usually accompanies the growth of malignant tissue.
ANTIANGIOGENIC MOLECULE: An orally delivered small-molecule formulation with antiangiogenic and
anticancer activity.
AROMATASE INHIBITORS (AI) (examples: anastrozole, exemestane and letrozole): A class of drugs used in
the treatment of breast cancer in postmenopausal women. Some cancers require oestrogen to grow. Aromatase
is an enzyme that synthesises oestrogen. Aromatase inhibitors block the synthesis of oestrogen. This lowers the
oestrogen level, and slows the growth of cancers.
AXILLA: The underarm or armpit.
AXILLARY DISSECTION: Surgery to remove lymph nodes from the armpit. The procedure can be performed either
at the same time as breast surgery or as a separate operation.
AXILLARY LYMPH NODES: Lymph nodes in and near the armpit.
BIOPSY: The removal of a small sample of tissue or cells from the body to help diagnose a disease.
BREAST CONSERVING SURGERY: Surgery to remove part of the breast. Also called a lumpectomy or a wide
local excision.
CHEMOTHERAPY (examples: cyclophosphamide, doxorubicin, docetaxel and capecitabine): The use of
medications (drugs) that are toxic to cancer cells. These drugs kill the cells, or prevent or slow their growth. The
standardised combination of such drugs in the treatment of cancer is referred to as a ‘treatment regimen’.
CLINICAL TRIAL: Research conducted with the participant’s consent which usually involves a comparison of two or
more treatments or diagnostic methods. Clinical trials are conducted to gain a better understanding of the underlying
disease process and/or methods to treat or prevent it. The clinical trial process includes Phase I, II, and III trials.
DOUBLE-BLIND TRIAL: A clinical trial in which neither the participating individual nor the study staff knows which
participants are receiving the experimental drug and which are receiving a placebo or another therapy.
DUCTAL CARCINOMA IN SITU (DCIS): Abnormal cells in the breast ducts, which over time could develop into
invasive breast cancer.
ELIGIBILITY CRITERIA: Participant eligibility criteria for clinical trials can range from general (age, type of cancer) to
specific (prior treatment, tumour characteristics, blood cell counts, organ function). Eligibility criteria may also vary
with the stage of the disease.
ENDOCRINE-RESPONSIVE: Another name for hormone-responsive, or hormone receptor-positive breast cancer.
Refer also to “hormone (endocrine) treatment”.
GOOD CLINICAL PRACTICE (GCP): An international standard for the design, conduct, performance, recording and
reporting of clinical trials; that provides assurance that the data and reported results are credible and accurate, and
that the rights, integrity and confidentiality of trial subjects are protected.
GRADE (TUMOUR GRADE): The degree of similarity of the cancer cells to normal cells. Grade is assessed by a
pathologist. Grade 1 carcinoma is well differentiated and is associated with a better prognosis. Grade 2 carcinoma
95
is moderately differentiated and is associated with an intermediate prognosis. Grade 3 carcinoma is poorly
differentiated and is generally associated with a worse prognosis.
HER2-POSITIVE (HER2-amplified): HER2 stands for Human Epidermal Growth Factor Receptor 2. In
HER2-positive breast cancer, the cancer cells have an abnormally high number of HER2 genes per cell. When this
happens, too much HER2 protein appears on the surface of these cancer cells. This is called HER2 protein over
expression or amplified. Too much HER2 protein is thought to cause cancer cells to grow and divide more quickly.
HORMONE (ENDOCRINE) TREATMENT: Hormone (endocrine) treatment is used to treat breast cancers that are
hormone receptor-positive, also known as hormone-responsive or endocrine-responsive. These cancers have
receptors for the hormones oestrogen and/or progesterone; they are called ER and/or PR-positive cancers. There
are several different types of hormone treatments. Some are taken as tablets (tamoxifen or aromatase inhibitors)
and some are treatments to turn off or remove the ovaries (injections, surgery and sometimes radiotherapy).
HORMONE RECEPTORS: Proteins in a cell which bind to specific hormones. This stimulates the cell to act in a
particular way.
HORMONE REPLACEMENT THERAPY (HRT): Drug therapy that supplies the body with hormones that it is no
longer able to produce; usually to relieve menopausal symptoms.
HORMONE-RESPONSIVE: Also known as hormone receptor-positive or endocrine-responsive breast cancer.
HUMAN RESEARCH ETHICS COMMITTEE (HREC): The Human Research Ethics Committee’s function is to review
proposed research in order to ensure that the subject’s rights are protected and that risk of harm is minimised.
HYPOTHESIS: Provides a suggested solution based on evidence.
INDEPENDENT DATA SAFETY AND MONITORING COMMITTEE (IDSMC): An independent group of experts or
adequately qualified individuals who monitor participant safety and treatment effectiveness data while a clinical trial
is ongoing.
INFORMED CONSENT: Informed consent is a process whereby a person gives consent based on a clear
understanding of the facts, any implications and possible future consequences. In the case of a clinical trial, these
facts, implications and consequences are conveyed in the Participant Information Sheet and any associated materials.
IPSILATERAL: On or affecting the same side of the body.
Isoform: Any of two or more functionally similar proteins that may have a similar but not identical amino acid
sequence, for example, there are two known isoforms of the oestrogen receptor, alpha (α) and beta (β).
LOCALLY ADVANCED BREAST CANCER: Breast cancer that has one or more of the following features: may be
large (typically bigger than 5 cm); may have spread to several lymph nodes in the armpit (axilla) or other areas near
the breast; and may have spread to other tissues around the breast such as the skin, muscle or ribs.
LUMPECTOMY: Also called “Breast Conserving Surgery”.
LYMPHOEDEMA: Swelling caused by a build-up of lymph fluid, as a result of lymph nodes being removed or not
working properly.
MAGNETIC RESONANCE IMAGING (MRI): A medical imaging device using a strong magnetic field and radio
frequency to produce detailed images of internal body parts and structures. MRI is especially useful for imaging soft
tissue like the brain, heart, muscles and tumours.
MAMMOGRAM: An x-ray of the breast.
MASTECTOMY: The surgical removal of the whole breast.
METASTATIC BREAST CANCER: Cancer that has spread from the original site in the breast to other organs or
tissues in the body. Also known as secondary breast cancer or advanced breast cancer.
MICROMETASTASES: Small cancer cells that have spread (metastases) beyond the primary tumour and can only
be detected by microscopic evaluation.
MONOCLONAL ANTIBODIES (examples: trastuzumab and bevacizumab): A treatment designed to specifically
target a cell within the body, particularly cancer cells. Different cancer types can be targeted with different
monoclonal antibodies.
96
MORBIDITY: The relative incidence of a particular disease within a defined population.
NEOADJUVANT: Treatment given prior to surgery or further treatment for cancer.
NODAL STATUS: Whether a breast cancer has spread (node-positive) or has not spread (node-negative) to lymph
nodes in the armpit (axillary nodes). The number and site of positive axillary nodes can help predict the risk of
cancer recurrence.
OESTROGEN: The main female sex hormone produced mostly by the ovaries.
OESTROGEN RECEPTOR (ER): A protein that may be present on certain cells to which oestrogen molecules can
attach. The term “ER-positive” refers to tumour cells that contain the oestrogen-receptor protein. These cells are
generally sensitive to hormone therapy.
OESTROGEN RECEPTOR ALPHA (ERα): One of two specific Oestrogen Receptor (ER) proteins. In standard
clinical practice ERα is the primary ER protein assessed when determining if a tumour is “ER-positive”.
OESTROGEN RECEPTOR BETA (ERβ): One of two specific Oestrogen Receptor (ER) proteins. ERβ is the less
common variation of the ER protein and is not routinely assessed in standard clinical practice.
ONCOLOGIST: A doctor who specialises in treating cancer.
ONCOLOGY: A branch of medicine that deals with cancer.
OOPHORECTOMY: The surgical removal of an ovary or ovaries.
OPEN-LABEL TRIAL: A clinical trial in which doctors and participants know which drug or treatment is being
administered.
OSTEOPOROSIS: A disease characterised by low bone mass and deterioration of bone architecture, which
increases the susceptibility to fractures.
PARTICIPANT INFORMATION SHEET: A document designed to provide participants with relevant information and
facts relating to the proposed clinical trial in order for the participant to make an informed decision regarding their
participation in the trial.
PARTICIPATING INSTITUTION: Any public or private hospital or facility where ANZBCTG clinical trials are conducted.
PHASE II CLINICAL TRIAL: The second stage of the evaluation of a new drug in humans; these trials evaluate
drug safety and preliminary efficacy (effectiveness) in a large number of participants (up to several hundred).
PHASE III CLINICAL TRIAL: The most rigorous and extensive type of scientific clinical investigation of a new
treatment. These trials are designed to determine the effectiveness of a treatment, often by comparing it to an
existing standard therapy or a placebo, in a large number of participants (typically hundreds or thousands). A phase
III trial is generally required before a drug would be approved by regulatory authorities for general use.
PLACEBO: An inert tablet (such as a sugar pill), liquid or powder that has no active ingredient. In clinical trials,
experimental treatments are often compared with a placebo to assess the treatment’s effectiveness.
PREVENTION TRIAL: A trial aiming to find better ways to prevent breast cancer in healthy women.
PRINCIPAL INVESTIGATOR (PI): The person responsible for overseeing all aspects of a clinical trial at an
ANZBCTG participating institution; submitting the protocol for institutional review board approval; recruiting
participants; obtaining informed consent; and collecting data.
PROGESTERONE RECEPTOR (PR): A protein that may be present on certain cells to which progesterone
molecules can attach. The term “PR-positive” refers to tumour cells that contain the progesterone-receptor protein.
These cells are generally sensitive to hormone therapy.
PROTOCOL: A written, detailed action plan for a clinical trial. The protocol provides the background, specifies the
objectives, and describes the design and organisation of the trial.
QUALITY OF LIFE: An individual’s overall appraisal of their situation and subjective sense of well-being.
RADIOTHERAPY: The use of radiation, usually x-rays or gamma rays, to kill cancer cells or damage them so they
cannot grow and multiply.
97
RANDOMISATION: A method of preventing bias in research by ‘randomly’ assigning clinical trial participants to
treatment groups. Randomisation ensures each treatment group has a similar range and number of participants,
such that any differences between treatment groups at the end of the trial can be attributed to the trial treatments.
RANDOMISED TRIAL: A study in which participants are randomly assigned to one of two or more treatment arms
of a clinical trial.
RECURRENCE: The return of breast cancer after a period of remission. During a recurrence, breast cancer cells
which have evaded treatment may reappear at the original site or in another part of the body.
RECURRENCE SCORE: Obtained by the Oncotype DX® Assay, is a numerical value between 0-100 representing
the likelihood of recurrence to distant parts of the body at 10 years post diagnosis.
SELECTIVE ESTROGEN RECEPTOR MODULATOR (SERM) (examples: tamoxifen and raloxifen): A class of
medication that acts on the oestrogen receptors of cells by blocking the effects of naturally produced oestrogen
within the body. This form of treatment has been shown to be effective in hormone-sensitive breast cancers.
SENTINEL NODE: The hypothetical first lymph node or group of nodes reached by metastasising cancer cells from
a primary tumour.
SENTINEL NODE BIOPSY: Sampling of the sentinel lymph node into which the primary tumour is draining first to
determine if a full lymph node exploration is needed.
SIDE EFFECTS: Unwanted effects of a drug or treatment (e.g. nausea, headache, hair loss, etc). Side effects may
be short or long term, ranging from minor inconveniences to serious adverse events.
STANDARD TREATMENT (THERAPY): The current best treatment known for a particular disease or condition.
STUDY CHAIR: An adequately qualified clinician assigned by the ANZBCTG to provide clinical advice and guidance
for the development and ongoing conduct of a clinical trial.
STUDY COORDINATOR: A member of the research team at an ANZBCTG participating institution who takes
responsibility for non-clinical aspects associated with the conduct of a clinical trial.
SYSTEMIC THERAPY: The use of chemotherapy, hormone therapy and/or targeted therapy or a combination of
these to target the entire body to destroy any cancer cells that may have spread to distant body parts but are below
the level of clinical detection.
TOXICITY: Harmful side effects from an agent being tested.
TREATMENT TRIALS: Treatment trials are designed to test the safety and effectiveness of new drugs, biological
agents, techniques, or other interventions in people who have been diagnosed with cancer. These trials evaluate the
new treatment against standard treatment, if there is one.
TRIPLE-NEGATIVE METASTATIC BREAST CANCER (TNBC): ‘Triple-negative’ is the term given to tumours which
do not possess Oestrogen Receptor (ER) and Progesterone Receptor (PgR) proteins, and which do not over
express the HER2 protein.
TYROSINE KINASE INHIBITOR (example: lapatinib): A drug that interferes with cell communication and growth
and which may prevent tumour growth.
98
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AR2010-2011
ANZBCTG Annual Report 2010-2011 99
Research for a world without breast cancer.

Annual Report - Breast Cancer Institute of Australia

Transcription

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