Celebrating 30 years - Breast Cancer Institute of Australia

Transcription

Australian New Zealand
Breast Cancer Trials Group®
Breast Cancer
Institute of Australia®
Annual Report
1 April 2008 - 31 March 2009
Celebrating 30 years
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 Division of the
ANZ Breast Cancer Trials Group Ltd
Telephone: (+61) 2 4925 3022
Web: www.bcia.org.au
©2009 This report cannot be reproduced without the permission of the
ANZ Breast Cancer Trials Group Ltd. All rights reserved.
Contents
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
Pre-operative Systemic Therapy Trials
22
Surgical Trials
24
Systemic Therapy Trials
25
Consumer Advisory Panel Report
35
Fundraising and Education Report
37
Fundraising Achievements and Highlights
39
Education Achievements and Highlights
53
Governance and Footprint
55
Contributors, Members and Supporters
63
Financial Report
79
Publications
85
Glossary of Terms
91
ANZ BCTG Annual Report 2008-2009
1
The Australian New Zealand Breast Cancer Trials Group (ANZ BCTG) has for 30 years conducted
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 80 institutions throughout Australia and New Zealand. Working together,
resources are pooled so that answers to important research questions can be made sooner, and with
greater scientific integrity for the benefit of women.
The ANZ BCTG has made, and continues to make, significant contributions to the control of breast
cancer and these are highlighted throughout this report.
Our Mission:
To eradicate all suffering from breast cancer through the
highest quality clinical trials research.
Our Vision:
To be a global and regional leader in research collaboration
committed to a world without breast cancer.
Our Values:
Excellent, relevant, transparent, reputable, inclusive, innovative.
Researchers and members of the
ANZ BCTG commemorate the
30th anniversary of the Group at
the 2008 Annual Scientific Meeting.
2
Chairman’s Report
The Australian New Zealand Breast Cancer Trials Group (ANZ BCTG) has conducted national and
international clinical trials in breast cancer since 1978. The Group is the leading breast cancer research
organisation in our region and our clinical trials program continues to make a major contribution to
breast cancer research globally.
As Chair of the ANZ BCTG’s Board of Directors I am pleased to be able to report excellent results for the
year from both a scientific and operational perspective. Highlights have been:
■■
celebrating our 30 year anniversary at our Annual Scientific Meeting in Wellington, New Zealand;
■■
implementation of new trials designed to answer clinically important questions that provide better
outcomes for women;
■■
peer-reviewed publication and dissemination of our research results that change clinical practice;
■■
continued excellent financial performance; and
■■
completion of a five year strategic plan, together with a supporting business plan.
Our membership, which is multidisciplinary and representative of all Australian states and territories and
New Zealand, has grown with 47 new members this year. In addition, our central office in Newcastle
NSW continues to offer employment opportunities for graduates and newly qualified oncologists
interested in pursuing a career in clinical research.
Strategic Planning
The ANZ BCTG’s five year Strategic Planning Framework (2009-2014) has been completed and approved
by the Board of Directors. The framework provides a clear articulation of the Group’s goals over the next
five years and the decisions, relationships, and tasks required to successfully achieve these goals.
As a part of this process the ANZ BCTG’s Mission, Vision and Values statements have been reviewed.
These statements reflect the essence of the Group and the principles which support the organisation.
Our mission “to eradicate all suffering from breast cancer through the highest quality clinical trials
research” and our vision “to be a global and regional leader in research collaboration committed
to a world without breast cancer” are very powerful, active words; words which truly describe the
ANZ BCTG’s current purpose and future directions.
Governance
The Group’s Constitution was reviewed and updated in 2008 to allow a change in Board membership
and the inclusion of up to three external appointed directors. The aim of these new appointments is
to broaden and strengthen the skills set of the Board, which has to date consisted solely of clinicians.
The number of elected directors has now reduced to eight (from nine, and will eventually reduce to six)
and the Nominations Committee of the Board is currently in the process of identifying potential new
appointed directors.
A reduction in the number of elected Board Directors saw the retirement of one of our
founding Board Directors, Professor John Forbes. John has dedicated his
professional career to the furtherance of breast cancer research
and the success of the ANZ BCTG. His remarkable
3
commitment to his patients and to those who are touched by breast cancer and his contributions to the
Group over 30 years is unsurpassed. John continues in the important role of Director of Research and
as a member of the Group’s Scientific Advisory Committee.
Financial Position
The Group’s financial position continues to improve with an increase in total revenue of 26% this year.
Equity has increased by just over 30% and financial performance ratios are indicative of an excellent
financial position. A significant part of this improvement was attributable to the success of our fundraising
activities (Breast Cancer Institute of Australia), the growth and prudent management of our clinical trials
research program and sustained infrastructure funding from Cancer Australia and Cancer Institute NSW.
Our members benefitted from the Group’s biannual Discretionary Funding opportunities and annual Avon
Travel Grants to attend our Annual Scientific Meeting. The Discretionary Funding awards supported pilot
or new research projects (in development or initial recruitment phase) and provided seed funding to new
institutions participating in our clinical trials program.
For more information on the ANZ BCTG’s financial position please refer to the Financial Report on page 79.
The Future
The future holds many opportunities to develop and expand the current ANZ BCTG clinical trials
research program for breast cancer. This is particularly so because of the Group’s healthy financial
position. We are working on the development of an increased ‘footprint’ (geographical and
multidisciplinary spread), active engagement with stakeholders, a branding and communications review
and further development of collaboration with other groups including consumers. We are also exploring
ways to further develop our mutually beneficial relationship with the pharmaceutical industry. This
relationship is critical to ensuring the Group continues to have access to new drugs for incorporation
into clinical trials with the potential to further improve breast cancer treatments and outcomes for women
with breast cancer or at risk of the disease.
In Summary
This has been a year of achievement and strategic development. The highlights have been an increased
availability of trials to women and members, a sustained increase in patient recruitment to clinical trials, a
continued improvement in our financial position and an increase in opportunities for growth and research
collaboration. There are many exciting projects on the horizon and innovative proposals which will
enhance the Group’s research program.
The ANZ BCTG’s activities are multi-faceted but fundamentally the Group’s core values are to be
excellent, relevant, transparent, reputable, inclusive and innovative. We will, therefore, continue to share
what we learn and appreciate the contribution of others in the pursuit of our research goals.
Finally, I would like to thank all the women who support and participate in ANZ BCTG clinical trials; all the
clinicians and ancillary medical staff who contribute to our research activities; the donors, funders and other
sponsors who sustain us; and the hard working committee and staff members who make it all happen.
Dr Jacquie Chirgwin
Chairman, Board of Directors
4
Chief Operating Officer’s Report
The ANZ BCTG is celebrating its 30th anniversary and, as mentioned elsewhere in this report, much has
been accomplished by the Group over this period. I personally am very proud to be associated with the
ANZ BCTG and to be part of this dynamic research organisation.
My role as the Chief Operating Officer of a large collaborative, academic breast cancer clinical trials
group is both challenging and very rewarding. I am responsible for the ANZ BCTG’s overall business
performance and I am supported in this position by a dedicated team of professionals who routinely go
‘above and beyond’.
The ANZ BCTG has grown substantially over the past ten years and a lot of work has been done
to develop an operational framework that effectively and efficiently supports this expansion. The
Group now employs 48 staff members at our central offices in Newcastle across three departments Business Administration, Trials Coordination and Fundraising and Education - and we aim to provide
career opportunities for those interested in clinical trials research, clinical trials management and notfor-profit fundraising.
Our achievements over the past year are summarised below.
Operations
■■
The ANZ BCTG Board of Directors approved the Group’s five year Strategic Planning
Framework (2009-2014) and identified four priority areas for 2009/2010 – Footprint (focussing
on collaboration), Relevant Trials Based on Excellent Science, Key Stakeholder Confidence and
Brand and Position. These priority areas and other strategic goals have been distilled into a
Business Plan which delivers the intent of the Framework according to predefined milestones and
objectives. An annotated version of the ANZ BCTG Business Plan is available from the members
section of our website.
■■
We moved to additional premises in January 2009 after outgrowing our offices at the NBN Telethon
Mater Institute, Waratah NSW. The new offices are located in central Newcastle and house the Business
Administration and Fundraising and Education departments. The relocation is supported by integrated
telephone and computer networks which ensure optimal communications can be maintained.
■■
We reviewed our operational Policies and Procedures (PnPs). The PnP review involved a needs
analysis, staff consultation, updating of existing PnPs, development of new PnPs, creation of
an improved ‘search’ facility and uploading of the final PnPs and associated attachments to the
ANZ BCTG intranet. The review process took five months and was a resounding success.
■■
We streamlined the use of character recognition software in our clinical trials data collection
processes. The system reduces the amount of manual data entry required and improves the Group’s
data query and resolution timelines. We also continued development of the ANZ BCTG Clinical Trials
Management Database (TMD). The TMD centrally manages standard clinical trials documentation and
monitoring activities and eliminates the repetition of administrative tasks which are common across all
ANZ BCTG trials.
5
Financial Position and Awarded Grants
■■
The ANZ BCTG completed the financial year (April 2008 – March 2009) in a strong position. The
Group was independently audited following the closure of the financial year and the surplus reported
is committed to current and future research projects. I would particularly like to highlight the success
of our fundraising activities which support essential research, education and capacity building
initiatives. For more information on the Group’s financial position please see the Financial Report
included in this Report.
■■
We were awarded additional competitive research grants from the National Health and Medical
Research Council (NHMRC). These grants are administered for the Group by the University of
Newcastle. We were also awarded a new competitive infrastructure grant from Cancer Australia as
part of the Strengthening Cancer Care - Support for Cancer Clinical Trials Program initiative. The
additional awards bring the Group’s grant holdings to just over $2 million for the reporting period.
In Summary
The Group is in a favourable position and ideally situated to take advantage of the potential opportunities
available from both a research and fundraising perspective. I look forward to enabling the Group to make
the best of these opportunities and to building the relationships necessary to achieve them.
I am forever grateful for the support of our funders, donors, members and collaborators. Without their
support we would not have such a successful research program. I am also thankful for the women
who, everyday, embrace our clinical trials and make such a vital contribution to improving breast cancer
outcomes for everyone.
Wendy Carmichael
Chief Operating Officer
6
Research Report
The ANZ BCTG commenced its clinical trials research program in 1978 with two trials in advanced
breast cancer (ANZ 7801/2). Today, we are celebrating 30 years as a leading national and international
clinical trials research organisation with the following major achievements:
■■
A robust research program encompassing more than 50 clinical trials (in various stages of
recruitment, follow-up, analysis and publication) for the prevention of breast cancer and for the
treatment of early and advanced breast cancer.
■■
Extensive research collaborations with more than 500 researchers and members representing 80
institutions throughout Australia and New Zealand and engagement with over 15 countries and other
international clinical trials groups.
■■
Involvement of more than 12,000 women from Australia and New Zealand in ANZ BCTG research
programs.
■■
Publication of 740 papers in peer-reviewed journals and continuous peer-reviewed grant support
since the inception of the Group.
The foundation of any successful research organisation is high quality scientific processes and an
inherent pursuit of excellence. The ANZ BCTG has always embraced these principles and they are
integral to everything we do. The Group ensures adherence to Good Clinical Research Practice
guidelines, unbiased scientific evaluation and review of research projects, and engagement with eminent,
experienced researchers and skilled trials management personnel.
The ANZ BCTG has a governance structure to enable the achievement of its mission - “to eradicate all
suffering from breast cancer through the highest quality clinical trials research”. It is the responsibility of
the ANZ BCTG Scientific Advisory Committee (SAC), chaired by Associate Professor Fran Boyle, to set
the Group’s research direction and the responsibility of the Group’s Director of Research, Professor John
Forbes, to manage the scientific and clinical conduct of the clinical trials program. The Chair of the SAC
and the Director of Research work together to drive the research agenda of the Group and to foster the
development of new research proposals.
The extent of the ANZ BCTG’s activities also requires a dedicated team of professionals to manage
the Group on a day to day basis. The central office in Newcastle NSW is managed by the Director
of Research and Chief Operating Officer and has three departments. It is the responsibility of the
Trials Coordination Department (TCD) to develop, activate and coordinate ANZ BCTG clinical trials.
This department has 29 staff members and is supervised by the Head of Trials Management, Mrs
Dianne Lindsay.
The ANZ BCTG’s Statistical Centre is located at the National Health and Medical Research Council
Clinical Trials Centre at the University of Sydney. The Statistical Centre provides statistical advice
on new projects, randomisation processes for current trials and statistical analyses of study results
for publication.
7
Along with our 30th anniversary, the ANZ BCTG has a number of other research highlights over the past year.
New Trials
This year the Group had its largest number of open clinical trials available for patient entry. One new trial was
commenced and in total 14 trials were open during the reporting period. This is a tremendous achievement and
testament to the hard work of the SAC, Director of Research and the TCD.
Recruitment to Trials
The enrollment of trial participants is vital for the successful completion of clinical trials. The ANZ BCTG
has initiated a number of successful recruitment strategies to identify and invite women to consider
participating in our research programs. The implementation of these strategies and the support of the
dedicated study coordinators and investigators at our participating institutions resulted in the ANZ BCTG
recruiting its largest number of clinical trial participants for more than five years – 581 new participants.
New Publications
As new trials begin, other trials reach their accrual targets, progress into follow-up phase and become
ready for analysis. During the reporting period, the ANZ BCTG added a further 46 publications to its
impressive track record of peer-reviewed publications.
Annual Scientific Meeting
In July 2008, the Group held its 30th Annual Scientific Meeting (ASM) in Wellington, New Zealand. The
ASM was attended by over 200 delegates and included workshops on patient communication and presurgical treatment, a consumer mentor program, two full days of scientific presentations and discussion.
We were delighted to welcome many international and local guest speakers to the ASM, who together
with distinguished members of the ANZ BCTG shared their knowledge with those in attendance.
The meeting celebrated the Group’s 30 year contribution to breast cancer research, culminating in
the conference dinner where Professor Forbes and Associate Professor Boyle presented a humorous
retrospective of the ANZ BCTG and its many contributors.
Moving Forward
One of the key challenges in optimising the care of women with breast cancer is personalising therapy
– identifying which drug treatments are likely to work best for which women. A new study, TAILORx,
will assess the usefulness of a new test (a gene ‘signature’) in predicting the benefit of chemotherapy in
early breast cancer.
In advanced breast cancer, strategies to improve control of the disease include the use of new drugs
which target the blood vessels which feed the cancer. This has the potential to improve the effectiveness
of chemotherapy – tackling cancer on two fronts simultaneously. The CIRG TRIO-012 study will test one
such ‘antiangiogenic’ therapy.
Important new research will be incorporated into the IBIS-II Prevention trial. High breast density, which
refers to a higher proportion of tissue to fat as seen on a mammogram, is strongly associated with an
increased risk of breast cancer. Breast density will be included as an eligibility criterion for patient entry
to the IBIS-II Prevention trial.
8
The Future
Clinical trials are the key to determining whether new treatment ‘discoveries’ from the laboratory can be
translated into clinical practice. All current breast cancer treatments will have been rigorously tested by
clinical trials before being made widely available to women in the community.
For 30 years, the ANZ BCTG has provided an effective framework for the conduct of collaborative breast
cancer clinical trials research in Australia and New Zealand. The Group’s longevity demonstrates its
ability to adapt in an ever-changing world, to seize opportunity and to consistently produce high quality
research results which can change clinical practice.
New research technologies, the discovery of new biological breast cancer ‘markers’ and other
clinical advances will affect the types of clinical trials that can be undertaken in the future. The
depth of the ANZ BCTG’s research expertise and the strength of its global relationships will ensure
the Group’s research program continues to be at the cutting edge and conscious of emerging
discoveries and opportunities.
We can be confident that our clinical trials will remain a crucial source of relevant and reliable
scientific data and will continue to provide important results that can be translated into better
outcomes for women.
Professor John F Forbes
Director of Research
Associate Professor Fran Boyle
Chair, Scientific Advisory Committee
Mrs Dianne Lindsay
Head of Trials Management
9
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10 ANZ BCTG Annual Report 2008-2009
Research Achievements and Highlights
The ANZ BCTG research program encompasses more than 50 clinical trials in various stages of
recruitment, follow-up, analysis and publication. It was the first Group in the world to include quality
of life and cost effectiveness questions in its research protocols and these activities remain a key
component of the Group’s research focus.
Currently, there are over 500 active ANZ BCTG members, representing 80 institutions throughout
Australia and New Zealand. The membership of the ANZ BCTG is representative of all relevant
medical disciplines including surgeons, medical oncologists, radiation oncologists, pathologists,
endocrinologists, haematologists, pharmacists, geneticists, psychologists, counsellors, study
coordinators, research nurses, consumers and other clinical trials management personnel.
Research achievements and highlights during the reporting period have been considerable and are
summarised below.
Clinical Trials Program
This year the ANZ BCTG had a record 14 clinical trials (including substudies) open for patient entry
(see Open Trials on Page 19). This, together with new recruitment processes, helped the ANZ BCTG
recruit 581 new participants to its clinical trials research program over the reporting period. The support
of research staff in the Trials Coordination Department and ANZ BCTG participating institutions was
essential to achieving this excellent result.
We were delighted to approve the participation of two new regional hospitals in the ANZ BCTG research
program - the North West Regional Hospital in Burnie, Tasmania and St Andrew’s Toowoomba Hospital
in Queensland.
The first patients were entered to two very important clinical trials during the reporting period and these
trials are briefly summarised below.
ANZ 0702 / BIG 2-06 / N063D / EGF106708 Adjuvant Lapatinib and/or Trastuzumab
Treatment Optimisation study (ALTTO)
Many breast cancer cells have growth receptor molecules on their surface. One particular type of growth
receptor is known as HER2. Patients with HER2-positive breast cancer have a greater risk of the cancer
returning after their initial treatment with trastuzumab.
Lapatinib is a new oral 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.
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. The first ANZ BCTG patient was entered to this study in April 2008.
For the first time we have a truly global trial as it involves collaboration with research groups from North
America, Europe and the ANZ BCTG all working together. This is the first such collaboration for an
adjuvant study and it will help to provide reliable results at the earliest opportunity.
11
IBCSG 35-07 / BIG 1-07 Study Of Letrozole Extension (SOLE)
After initial treatment for hormone-responsive breast cancer, standard long term treatment usually
includes at least five years of hormone treatment. For postmenopausal women, hormone treatment
usually consists of an aromatase inhibitor such as letrozole. 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. Results from some smaller studies indicate that short breaks from letrozole
treatment may make letrozole-resistant breast cancer cells more vulnerable to letrozole treatment when
the treatment is restarted.
The international trial SOLE, is evaluating whether having three-month treatment-free periods, during five
years of extended letrozole treatment, will further prevent or delay breast cancer from returning. The first
ANZ BCTG patient was entered to this study in February 2009.
Patterns of Recurrence
The ANZ BCTG conducted a ‘Patterns of Recurrence Survey’ during the reporting period. It is hoped
that by identifying the characteristics of consecutive relapsing patients the survey results will:
■■
support the design of new relevant ANZ BCTG clinical trials in the metastatic disease setting; and
■■
help the ANZ BCTG to design clinical trials in the adjuvant setting that address the needs of women
at greater risk of recurrence.
Survey responses were completed in December 2008 and data analysis is underway.
Publications
During the reporting period, the ANZ BCTG added a further 46 publications to its portfolio (see
Publications on Page 85). Eight of these publications are summarised briefly below.
ATAC 100 month follow-up
The 100 month follow-up analysis of the ATAC (Arimidex®, Tamoxifen, Alone or in Combination) trial
was published in The Lancet in 2008 (9:45-53). These results showed that anastrozole (Arimidex®),
compared to tamoxifen, can significantly reduce the risk of recurrence and minimise serious side effects
for postmenopausal women with hormone-sensitive early breast cancer. The data also showed that the
protective effect of anastrozole lasts well beyond the standard treatment period of five years. Overall,
women in the ATAC trial taking anastrozole were 24% less likely to have their breast cancer return
compared with those taking tamoxifen.
This data strengthens the evidence for the use of anastrozole in preference to tamoxifen, soon after
diagnosis for five years, to give postmenopausal women with hormone-sensitive early breast cancer the
best chance of remaining breast cancer-free long term. Internationally, 9,306 women were recruited to
the ATAC trial and 11 ANZ BCTG institutions participated.
ATAC – a retrospective analysis of some early side effects of hormone treatment
Women who experience side effects from their treatment for hormone-sensitive breast cancer may
derive greater benefit from this treatment. The aim of this research was to conduct a retrospective
analysis of side effects, such as joint pain and hot flushes, reported by women taking part in the ATAC
(Arimidex®, Tamoxifen, Alone or in Combination) trial to see if there was a relation to breast cancer
recurrence. It was published in Lancet Oncology in 2008 (9(12):1143-1148).
The data showed that the appearance of new side effects during the first three months of hormone
treatment suggested that the patient was experiencing a better response. Women who received either
tamoxifen or anastrozole (Arimidex®), and experienced early joint symptoms, hot flushes or sweats after
starting hormone treatment, had fewer breast cancer recurrences in the longer term. Awareness of the
relation between the appearance of early side effects and the potential longer term benefits of hormone
treatment may reassure women, and help improve treatment compliance.
BIG 1-98 / IBCSG 18-98
This analysis, which explored potential differences in efficacy, treatment completion and adverse events
in postmenopausal women taking part in the international trial BIG 1-98, was published in the Journal
of Clinical Oncology in 2008 (26(12):1972-1979). BIG 1-98 evaluated an aromatase inhibitor, letrozole,
as adjuvant endocrine therapy for postmenopausal women with receptor (ER and/or PgR) positive early
breast cancer. The objective of this analysis was to assess the monotherapy arms, letrozole alone and
tamoxifen alone (4,922 patients), and the age of the patient at the time of diagnosis and treatment. Age
groups of women ‘younger than 65 years’, ‘65 to 74 years’ and ‘elderly, 75 years or older’ were reviewed.
Results from this study showed that, for a small number of women older than 75 years, tamoxifen
may be a better treatment option if there are existing risk factors for cardiovascular disease, or a prior
diagnosis of osteoporosis. In contrast, letrozole may be a better treatment option for older women
who have a prior history of thromboembolic disease. The most important information obtained from
this analysis was that letrozole is a more effective treatment than tamoxifen for all age groups of
postmenopausal women.
IBCSG VIII and IX – Ki-67 analysis
Prior studies suggest that the presence of a high percentage of Ki-67 expression (a biomarker) in breast
cancer tumour cells predicts a better response to adjuvant chemotherapy. The goal of this research
was to test Ki-67 levels in tumour samples collected from women with lymph node-negative, hormonesensitive breast cancer who were participating in the IBCSG VIII and IX trials. Internationally, 1,111
women were recruited to IBCSG VIII with the ANZ BCTG contributing 20% (228) of this total, and 1,715
women were recruited to IBCSG IX with the ANZ BCTG contributing 19% (330). The two studies were
conducted between 1988 and 1999 and compared adjuvant endocrine therapy alone with sequential
chemotherapy followed by endocrine therapy alone.
The aim of the Ki-67 analysis, published in the Journal of the National Cancer Institute in 2008
(100:207-212), was to examine the tumour samples to determine if Ki-67 could identify patients who
might benefit from receiving endocrine therapy and chemotherapy.
The data showed that levels of Ki-67 did not predict which patients may benefit from receiving
chemotherapy in addition to endocrine therapy in the adjuvant treatment setting. A high Ki-67 level was
associated with worse disease-free survival in all treatment groups. The authors noted that there were
limitations in this study, and that other biomarkers are needed to identify which women with
hormone-sensitive, node-negative, early breast cancer should receive treatment with
both endocrine therapy and chemotherapy.
13
BIG 2-98 / IBCSG 20-98
Results of the international trial BIG 2-98 were published in the Journal of the National Cancer Institute in
2008 (100:121-133).
This trial tested two significant questions:
1. C
an incorporation of the taxane docetaxel (Taxotere®) into anthracycline (doxorubicin)-based adjuvant
chemotherapy reduce the risk of relapse in node-positive breast cancer?
2. If docetaxel does confer an advantage, what is the best way to deliver this treatment? Is it in
combination with doxorubicin or sequentially after doxorubicin?
This trial demonstrated that the timing of docetaxel treatment may be of significance, with sequential
treatment after doxorubicin appearing to produce better disease-free survival than if it was given at the
same time as doxorubicin based chemotherapy. These results may be of more importance for women
who have oestrogen receptor-negative breast cancer or women whose breast cancer has spread to
several lymph nodes.
A total of 2,887 women were recruited internationally to this trial and 605 (21%) of these women were
enrolled by ANZ BCTG institutions.
IBCSG 11-93
The ten year update of trial IBCSG 11-93 was published in Breast Cancer Research and Treatment
in 2009 (113:137-144). This phase III trial involved premenopausal women who after surgery for
their breast cancer were found to have tumours which are hormone-sensitive and positive axillary
lymph nodes. For these women it was not known whether hormonal treatment alone was sufficient,
or whether the addition of chemotherapy would be beneficial in reducing the incidence of disease
recurrence and improve survival. Internationally, 174 women were recruited to this study and 13
ANZ BCTG institutions participated.
The trial was closed before the target accrual was reached due to a low accrual rate. IBCSG 11-93
is the only published randomised comparison addressing the role of chemotherapy in this group of
premenopausal patients. Although small, it offers no evidence that anthracycline chemotherapy provides
additional disease control for premenopausal patients with lower-risk node-positive, endocrine-responsive
breast cancer who receive adequate adjuvant endocrine therapy. Another large, well-designed trial is
needed to determine whether this group of patients derive benefit from the addition of chemotherapy.
IBIS-II DCIS – Decision Aid
This pilot study aimed to improve the process of obtaining informed consent from patients to enter
clinical trials. A Decision Aid booklet was designed for the IBIS-II DCIS trial, which compares the efficacy
of the aromatase inhibitor anastrozole with tamoxifen in women who have had surgery for Ductal
Carcinoma In Situ (DCIS). Women participating in an earlier prevention trial, IBIS-I, were selected to
evaluate the booklet.
The results published in Health Expectations in 2008 (11:252-262) suggest that a Decision Aid would
be acceptable to potential participants in the IBIS-II DCIS trial. It was acknowledged that the process
of obtaining informed consent is complex, and that there are a number of factors which may motivate
women to take part in a clinical trial.
Group Clinical Trials – Standards for Specimen Collection
The adoption of unified standards for the collection and storage of tumour tissue and blood specimens
is essential to maximise specimen based diagnostic testing and research. Experts from leading
international collaborative groups, including the ANZ BCTG, formed a working group to assess and
improve current tissue collection procedures. A set of procedures was agreed and documented in a
paper published in the Journal of Clinical Oncology in 2008 (26(34):5638-5644).
Standard guidelines for specimen collection, handling and shipping are documented in the paper. These
guidelines will help to ensure that the quality of valuable trial specimens is maintained and that important
translational research can be performed for global clinical trials. Other goals that were initiated by the
working group include sharing trial designs and strategies, combining analyses, sharing ideas about
future translational research and collaboration on translational research projects.
The ANZ BCTG held its 30th Annual Scientific Meeting (ASM) in July 2008 at the Te Papa Tongarewa
Museum of Wellington, New Zealand. The ASM facilitates the global sharing of research knowledge and
information which is critical to the control of breast cancer.
More than 200 researchers and specialists from throughout Australia and New Zealand attended the
Wellington meeting. We are particularly grateful to our international and local colleagues (listed below)
whose participation in our meeting was of great benefit to all those in attendance.
■■
Professor Robert Baxter, University of Sydney
■■
Professor Richard Gelber, Dana-Farber Cancer Institute, Boston US
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Professor Ian Kunkler, Edinburgh Cancer Research Centre, Edinburgh UK
■■
Professor Peter Lobie, Liggins Institute, Auckland NZ
■■
Dr Kevin Lynch, Celgene Pty Ltd, Melbourne
■■
Ms Margo Michaels, ENACCT, Silver Spring US
■■
Associate Professor Cristin Print, The University of Auckland, NZ
■■
Dr Kathy Pritchard, Sunnybrook Regional Cancer Center, Toronto Canada
■■
Associate Professor Papaarangi Reid, The University of Auckland, NZ
■■
Professor John Robertson, University of Nottingham, UK
■■
Dr Hope Rugo, UCSF Breast Care Center, San Francisco US
■■
Associate Professor Linda Vahdat, Weill Cornell, New York US
■■
Professor William Wilson, The University of Auckland, NZ
ASM Awards and Travel Grants
This year the ANZ BCTG Board of Directors established the John Collins Medal and Travel Grant to
encourage potential academic breast surgeons and registrars to become involved in clinical trials
research. In 2007, the Data Manager Award was established to recognise outstanding commitment to
the ANZ BCTG by a study coordinator.
The ANZ BCTG Board also established Travel Grants to assist breast cancer researchers and study
coordinators to attend the annual ASM, who might otherwise not have had the opportunity
largely due to funding issues. Both these initiatives are sponsored by Avon, which
together with the ANZ BCTG is committed to encouraging and fostering
the best, new breast cancer researchers.
15
The 2008 recipients are as follows:
John Collins Medal and Travel Grant: Miss Anita Skandarajah, Royal Melbourne Hospital, VIC
Travel Grants: Miss Leeanne Greenhalgh, St Vincent’s Hospital, VIC
Mr Mafizul Hoque, Bankstown-Lidcombe Hospital, NSW
Miss Laura Mackay, Auckland City Hospital, New Zealand
Mrs Sharon Maliepaard, Frankston Hospital, VIC
Mrs Jennifer McGuiggan, Launceston General Hospital, TAS
Dr Kate Richards, Peter MacCallum Cancer Centre, VIC
Mrs Judith Silcock, The Breast Centre, NSW
Mr Allan Smith, University of Sydney, NSW
Mrs Suzanne Wegecsanyi, Sir Charles Gairdner Hospital, WA
ANZ BCTG Data Manager Award: Ms Jenni Scarlet, Waikato Hospital, New Zealand
New Appointments and Processes
Clinical trials coordination is an exciting and challenging activity which requires interaction with many
different people, groups and organisations. The ANZ BCTG Trials Coordination Department (TCD)
has responsibility for many facets of the Group’s research program including: development of new
trial protocols; inclusion of new participating institutions; activation of trials; monitoring, collection,
entry and cleaning of clinical trial data; coordination of trial quality assurance activities; organisation of
trial data analyses in liaison with the Statistical Centre and Independent Data Safety and Monitoring
Committee; formatting of trial publications and dissemination of clinical trials results to our membership;
and education and training of study coordinators, research nurses and investigators in ANZ BCTG
trial processes.
The TCD is continually reviewing its procedures to ensure maximum support can be provided to our
participating institutions and activation of ANZ BCTG trials can be as seamless as possible. In 2008, for
example, new technologies were implemented to streamline our data collection processes. This new
technology uses Optical Character Recognition software to reduce the amount of manual data entry
required and improve the Group’s data query and resolution timelines. The design of the members’ area
of the clinical trials section of the ANZ BCTG website has also been improved. This online resource
provides valuable information and materials necessary for the activation and ongoing management of
ANZ BCTG clinical trials at all participating institutions.
A new database has been designed to assist the TCD to further improve the management of clinical
trials during the activation, treatment and follow-up phases. Maintaining compliance with regulatory
requirements for clinical trials research is critical. This new database is unique and will standardise the
collection of complex information across the entire research program. It will also assist research staff at
participating institutions as reports will be available to these staff on the ANZ BCTG website, reducing
the administrative workload associated with conducting clinical trials research.
In December 2008, the ANZ BCTG appointed a Medical Fellow, Dr James Bull. 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 ANZ BCTG. The position is funded by
the Cancer Institute NSW and the input provided by Dr Bull has been invaluable.
Discretionary Research Funding
During the reporting period the ANZ BCTG provided opportunities for its members to apply for
Discretionary Research Funding. This funding is available to pilot projects or projects which require some
seed funding to get started. The proposals must have Scientific Advisory Committee approval and be
either related to existing ANZ BCTG research activities or relevant to the overall research agenda of the
ANZ BCTG. Funding for this initiative comes from public donations made to the Group, without which
these important projects could not be supported.
Dr P Francis, Trial BIG 2-98 / IBCSG 20-98 – An application was approved for funding to support
data management services and statistical services for an unplanned analysis of outcomes for women
in this study according to loco-regional treatments received relative to other relevant variables (eg nodal
status, age).
Dr P Francis, Trial IBCSG 25-02 / BIG 3-02 (TEXT) retrospective sample collection – An application
was approved for funding to support retrospective blood sample collection (which is part of the TEXT
protocol re-activation amendment) for the 191 ANZ BCTG patients currently enrolled in the TEXT trial.
Assoc Prof K Phillips, Triple-negative phase II trial – An application was approved for funding to
support the pilot stage of a phase II clinical trial to evaluate the efficacy of tamoxifen in triple-negative but
oestrogen receptor β positive breast cancer.
Prof M King, Pilot patient preferences substudy for the ANZ 0702 (ALTTO) trial – An application
was approved for funding to support the pilot phase of a Discrete Choice Experiment to assess patient
preferences to treatments in the ALTTO trial.
Discretionary Site Infrastructure Funding
During the reporting period the ANZ BCTG provided opportunities for its members to apply for
Discretionary Site Infrastructure Funding. Funding for this initiative comes from public donations made to
the Group, without which these essential requests could not be supported.
Sir Charles Gairdner Hospital (WA) – An application was approved for funding to assist with the
activation of the ANZ 0501 (LATER) trial at this centre.
St Andrew’s Toowoomba Hospital (QLD) – An application was approved for funding to assist the
establishment of a new research centre and activation of ANZ BCTG trials IBCSG 34-05 / SWOG S0230
(POEMS) and IBCSG 24-02 / BIG 2-02 (SOFT).
North West Regional Hospital (TAS) – An application was approved for funding to assist the
establishment of breast cancer research at this new centre and activation of ANZ BCTG trials
IBCSG 35-07 / BIG 1-07 (SOLE), ANZ 0501 (LATER), IBCSG 24-02 / BIG 2-02 (SOFT) and
ANZ 0701 (Co-SOFT).
17
Clinical Trials Open for Patient Entry
Prevention Trials
Prevention clinical trials have mainly involved women with an increased risk of breast cancer, usually due
to a strong family history of the disease.
The recruitment of women to these trials requires support from many different quarters including
surgeons; medical, radiation and surgical oncologists; study coordinators; general practitioners and the
public. Women who are invited to participate in prevention clinical trials have either never had breast
cancer or are long term breast cancer survivors.
Our prevention research is threefold: to prevent breast cancer in women at high risk, to prevent breast
cancer recurrence in women who have had the disease, and to ultimately prevent breast cancer for all.
The first international breast cancer prevention trial, IBIS-I, began in 1992 and involved seven countries
and 7,154 women. The ANZ BCTG enrolled 2,674 women from Australia and New Zealand.
In 2002, results from IBIS-I demonstrated that tamoxifen, a well established therapy for the treatment of
breast cancer, reduced the occurrence of hormone receptor-positive breast cancer by about one third 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. This
research, together with ongoing data from our treatment clinical trials, provides us with new strategies
for use in the prevention setting.
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 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.
19
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 ANZ BCTG has enrolled 401 women to the IBIS-II Prevention trial and 93 women to the IBIS-II DCIS
trial (31 March 2009).
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)
ANZ BCTG Study Chair:
Prof John F Forbes (Calvary Mater Newcastle)
First ANZ BCTG Participant Enrolled: 22 March 2006 (IBIS-II Prevention)
18 November 2005 (IBIS-II DCIS)
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
T ≥ -1.0
-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.
ANZ 0501 Later adjuvant Aromatase inhibitor Therapy for postmenopausal women with
Endocrine-Responsive breast cancer (LATER)
A randomised double-blind trial in postmenopausal women who have completed five years of adjuvant
endocrine therapy for early, hormone-sensitive breast cancer more than one year previous and who are
disease-free at study 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 six 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.
The ANZ BCTG has enrolled 36 women to the LATER trial (31 March 2009).
The LATER trial is supported by a NHMRC Project Grant (2008-2012).
ANZ BCTG
ANZ BCTG Study Co-Chairs:
Assoc Prof Michael Green (Royal Melbourne Hospital)
First ANZ BCTG Participant Enrolled:
16 May 2007
Patient Population
Postmenopausal
Stratification
Institution
ER and/or PgR+ early BC
AET for 5 years
AET completed ≥ 12
months*
Disease-free BC
AET:
LET:
PLAC:
Node status: N+/N-/UNK
AET: TAM/AI/Other
R
A
N
D
O
M
I
S
A
T
I
O
N
LET for 5 years
PLAC for 5 years
adjuvant endocrine therapy
letrozole 2.5 mg daily po
placebo daily po
* Study entry will be ≥ 6 years after diagnosis of primary breast cancer.
21
Pre-operative Systemic Therapy Trials
Traditionally, chemotherapy and endocrine treatments (systemic therapy) have been given once
a patient has undergone surgery for breast cancer. However, more recently, interest has arisen
in administering these therapies before surgery (known as pre-operative systemic therapy or
neoadjuvant therapy).
Pre-operative therapy can substantially reduce the size of a primary breast tumour to allow for
breast conserving surgery and surgical resection of previously inoperable tumours. Other potential
benefits of pre-operative therapy include the ability to gain systemic control of micrometastatic
disease and to assess the sensitivity of an individual tumour to chemotherapy drugs that might be
used for post-operative treatment.
Trials can also be designed to plan post-operative treatments which are based on tumour
response and biological change. Women could avoid morbidity from ineffective systemic therapy
and important biological information relevant to pathways, targets and resistance to therapies may
come only from this approach.
The administration of pre-operative therapy requires the support of the entire oncology team as
they must work together to deliver treatments for selected patients in this setting. Surgeons in
particular should be informed about potential pre-operative research initiatives as they are the
gatekeepers for the treatment of early breast cancer.
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.
Larger breast cancers are usually associated with a poorer prognosis and a higher risk that the
disease has spread beyond the breast. Standard treatment for this type of breast cancer involves
extensive surgery such as a mastectomy and also the removal of lymph nodes from the armpit. A
course of chemotherapy (adjuvant chemotherapy) will usually follow to eliminate any small tumour
cells that may remain undetected.
The NeoGem trial has been developed by researchers of the ANZ BCTG and investigates the benefit
of giving chemotherapy prior to surgery (pre-operative systemic therapy). Study treatment includes
an initial course of standard chemotherapy (epirubicin and cyclophosphamide) followed by a course
of newer chemotherapy drugs for breast cancer (docetaxel and gemcitabine). Women diagnosed
with a type of breast cancer known as HER2-positive also receive trastuzumab (Herceptin®). It
is hoped that with this treatment the size of the tumour will be reduced, allowing any remaining
tumour to be removed by breast conserving surgery. Small samples of tumour tissue and blood
are collected before and after chemotherapy. This type of research may identify treatments that are
more effective for different types of breast cancer, leading to treatments tailored to the needs of
individual patients.
This trial will have its interim safety and efficacy analyses in 2009. It will provide a unique tissue
resource for translational research, and a NHMRC Project Grant has been submitted for some of
this work in collaboration with the Kolling Institute at the University of Sydney. This trial also has a
sentinel node substudy.
The ANZ BCTG has enrolled 77 participants to this trial (31 March 2009).
The NeoGem trial is supported by a NHMRC Project Grant (2007-2009).
ANZ BCTG
Dr Nicole McCarthy (Royal Brisbane and Women’s Hospital)
Prof Bruce Mann (Royal Melbourne Hospital) – Sentinel Node Substudy
30 August 2006
Patient Population
Operable unilateral primary
breast cancer clinically
T2 ≥ 3 cm only, T3-4,N0-1,M0,
diagnosed by core biopsy
HER2+ or HER2Age ≥ 18 years
No prior chemotherapy
or hormonal therapy for
invasive malignancy
R
E
G
I
S
T
R
A
T
I
O
N
S
HER2-
DG x 4
R
G
EC x 4
E
HER2+
DGT x 4
R
Y
EC (4 cycles)
E:
epirubicin
C:
cyclophosphamide
90 mg/m2
600 mg/m2
DG (4 cycles)
D:
docetaxel
G:
gemcitabine
75 mg/m2
day 1
1000 mg/m2 days 1 & 8
DGT (cycle 1)
T:
trastuzumab
D:
docetaxel
G:
gemcitabine
T:
trastuzumab
4 mg/kg
75 mg/m2
1000 mg/m2
2 mg/kg
DGT (cycle 2 to 4)
D:
docetaxel
75 mg/m2
G:
gemcitabine
1000 mg/m2
T:
trastuzumab
2 mg/kg
T:
trastuzumab
6 mg/kg
U
T to 1
year
day 1
day 1
day 1
day 2
day 2 & 8
day 8 & 15
day 1
day 1 & 8
day 1, 8 & 15
day 22 of last cycle then every 3 weeks
(up to a total of one year of therapy)
Tissue collection (tumour biopsies and serum):
Pretreatment:
EC x 2:
DG or DGT:
Definitive surgery:
5 core biopsies (3 FFPE and 2 cores of frozen tissue); frozen serum sample.
after completing 2 cycles: 2 core biopsies (1 FFPE, 1 frozen fresh tissue);
frozen serum sample.
before first dose DG/DGT: frozen serum sample.
4 mm punch biopsy of residual tumour / areas of fibrotic stroma (frozen fresh tissue); a
minimum of 10 FFPE blocks, including a sample from the axillary nodes, if possible; and frozen serum sample.
23
Surgical Trials
The aim of surgery for breast cancer is to obtain maximum benefit with minimum morbidity and
optimal cosmesis (the appearance of the breast after surgery). This has been a long term
challenge for breast surgeons given that adequate tumour resection has a direct correlation to
long term survival.
Until recently, the standard surgical treatment for breast cancer was to remove the breast or
cancerous lump from the breast, and also to remove the lymph nodes under the arm (axillary
dissection) in order to test these nodes for the presence of breast cancer cells. The development of
new surgical techniques has refined this process and today a procedure called sentinel node biopsy
is used. This technique determines whether breast cancer cells have spread to the lymph nodes
under the arm by only removing the ‘sentinel’ node (the node that the cancer usually spreads to
first). If a surgeon finds that the sentinel node has no cancer cells the removal of additional axillary
lymph nodes can be avoided. The sentinel node biopsy procedure reduces the number of breast
cancer patients who need to have an axillary dissection and also the potential side effects of having
this surgery including lymphoedema.
The advent of sentinel node biopsy has resulted in opportunities for further research. In particular,
it has been noted that although a sentinel node sometimes does not contain clear evidence of
metastatic spread of the cancer, it does contain tiny clumps of abnormal cells seen only under the
microscope. These cells are called “micrometastases” and their size is less than 0.2 mm. Their
significance to breast cancer outcomes is not known. Hence there can be a dilemma for the treating
surgeon and the woman, as to whether the finding of micrometastases should mean that additional
axillary lymph nodes should be removed, with a potential negative impact on quality of life, or
whether they can be ignored.
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.
This international clinical trial will determine if the extent of axillary surgery can be reduced for
women with good prognosis early breast cancer who have only small clumps of cancer cells, called
micrometastases, found in the sentinel lymph nodes. It may be that the long term prognosis for
patients when there are micrometastases in sentinel nodes is the same as when no cancer cells are
found. If the prognosis is the same, it may be possible to avoid removal of all the axillary nodes in
these patients.
All patients taking part in this trial receive additional standard therapy following surgery to further
reduce the growth of any remaining cancer cells. This trial studies factors such as the rate of breast
cancer recurrence (return of the cancer), and short and longer term complications of surgery.
IBCSG 23-01 is of considerable importance in terms of improving outcomes for women with breast
cancer and also in understanding breast biology.
The ANZ BCTG has enrolled 25 of the 730 patients participating in this trial internationally
(31 March 2009).
International Breast Cancer Study Group (IBCSG)
ANZ BCTG Study Co-Chairs:
Assoc Prof Ian Campbell (Waikato Hospital, NZ)
Prof John Collins (Royal Melbourne Hospital)
2 March 2006
Patient Population
Breast carcinoma
( ≤ 5 cm macroscopic)
Clinically
node-negative
One or more
micrometastatic
sentinel lymph
nodes (≤ 2 mm;
no extracapsular
extension)
Stratification
Institution
Menopausal
status
Preoperative SNB
under local
anaesthesia
(Y/N)
SNB
* Pathological exam
Primary BC surgery
Pathological exam of
primary tumour
R
E
G
I
S
T
R &
A
T
I
O
N
R
A
N
D
O
M
I
S
A
T
I
O
N
A
Ax
B
no Ax
* Confirmation that the primary tumour is macroscopically ≤ 5 cm, one or more micrometastatic (≤ 2 mm) sentinel node(s), with no extracapsular extension by pathological examination.
Adjuvant treatment: patients will be eligible for enrolment in protocols of the IBCSG. (Section 5.4 of
protocol)
Ax:
axillary lymph node dissection
SNB: sentinel node biopsy
Systemic Therapy Trials
Breast cancer may spread from the breast to other parts of the body through the lymphatic system
and blood vessels. This can lead to subsequent recurrence of breast cancer as a secondary cancer
in another organ (known as advanced or metastatic breast cancer). The use of systemic drug
therapies after surgery, for example chemotherapy, has been proven to reduce the risk of breast
cancer recurrence and has saved many lives over the past 30 years.
Changes in adjuvant therapy over recent years, due to the greater use of aromatase inhibitors,
taxanes, other systemic therapies and trastuzumab, means that fewer women are relapsing,
however, those who do relapse clearly require different, more targeted types of treatment.
Current systemic therapy trials therefore aim to refine drug treatments in particular subgroups of
women who remain at higher risk of recurrence despite standard treatments. This includes women
whose cancers do not express hormone receptors (ER/PR-negative), or over express HER2
receptors (HER2-positive); or women who are very young.
25
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), which stops 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. It is possible that using lower doses of chemotherapy drugs for a
longer period may be more effective, patients 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, breast cancer patients are evenly divided between two groups. One group will receive
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 ANZ BCTG has enrolled 56 of the 793 patients participating in this trial internationally
(31 March 2009).
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
* Approved induction chemotherapy regimens
C: cyclophosphamide 50 mg/day orally
M: methotrexate
2.5 mg/twice a day orally
Before
induction
chemotherapy
begins or any
time prior to
day 56** of the
last cycle of
induction
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
A
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.
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.
The ANZ BCTG has enrolled 189 of the 2,276 patients participating in this trial internationally
(31 March 2009).
The SOFT trial is supported by a NHMRC Project Grant (2008-2010).
Lead International Group: International Breast Cancer Study Group (IBCSG)
ANZ BCTG Study Chair: Dr Prue Francis (Peter MacCallum Cancer Centre)
17 March 2005
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.
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.
Standard treatments for hormone-responsive breast cancer (such as tamoxifen and exemestane) work
by interfering with the action of oestrogen and therefore, may have an effect on brain functions such as
memory and thinking.
The ANZ BCTG has taken the international lead in developing the substudy Co-SOFT which uses
computerised card memory games and questionnaires to monitor changes in brain function before,
during and after breast cancer treatment for patients taking part in the parent SOFT trial.
The ANZ BCTG has enrolled five of the 16 patients participating in this trial internationally (31 March
2009).
The Co-SOFT substudy is supported by a NHMRC Project Grant (2007-2011).
27
ANZ BCTG
Assoc Prof Kelly-Anne Phillips
(Peter MacCallum Cancer Centre)
7 November 2007
Patient Population
Stratification
Institution
R
Premenopausal women
with histologically proven
hormone receptor-positive
breast cancer
G
ER ≥ 10% and/or PgR ≥ 10%
E
Number of positive nodes
(0;1 or more)
No CT stratum
(randomise after surgery)*
S
U
R
Y
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
Years
TAM x 5 yrs
OFS + TAM x 5 yrs
OFS + EXE x 5 yrs
0 1 2 3 4 5 6
Cognitive Function Assessments
CT:
chemotherapy ≥ 2 months duration if anthracycline included;
≥ 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
* Patients may have received tamoxifen or aromatase inhibitor prior to randomisation.
Patients must remain premenopausal after chemotherapy.
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.
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 stopping ovarian activity 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 patients who should receive ovarian function
suppression from the start of their adjuvant breast cancer treatment.
The ANZ BCTG has enrolled 191 of the 2,050 patients participating in this trial internationally (31 March 2009).
The TEXT trial is supported by a NHMRC Project Grant (2008-2010).
ANZ BCTG Study Chair: Dr Prue Francis (Peter MacCallum Cancer Centre)
First ANZ BCTG Participant Enrolled: 15 September 2006
S
U
R
G
E
R
Y
Patient Population
Stratification
Premenopausal women
with histologically proven
hormone receptor-positive
breast cancer
Institution
ER ≥ 10% and/or
PgR ≥ 10%
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.
29
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: Chemotherapy versus Observation.
Standard breast cancer treatment may involve surgery followed by a combination of radiotherapy,
chemotherapy and/or hormone therapy (a drug which stops the body’s natural hormones from feeding
the cancer). Despite these treatments the cancer may return to the same area (the breast, surgical scar,
chest wall, or armpit) for a small number of patients. If the breast cancer returns to the same area, it is
not clear if further chemotherapy will provide any additional benefit.
Given the impact of chemotherapy on quality of life, it is important to understand how effective the
addition of chemotherapy is at preventing the tumour from returning a second time or spreading to other
areas of the body. This trial aims to answer this question. All patients receive the standard treatment
(surgery and/or radiotherapy and/or hormone therapy). In addition, one half of patients also receive
chemotherapy.
The ANZ BCTG has enrolled two of the 147 patients participating in this trial internationally (31 March
2009).
Assoc Prof Fran Boyle (Mater Sydney)
12 April 2006
Patient Population
First loco-regional
relapse invasive breast
cancer
Surgical resection ± RT
No distant metastases
Suitable for
3-6 months CT
Stratification
S
U
R
G
E
R
Y
Endocrine therapy:
CT: chemotherapy:
RT: radiotherapy:
Prior CT (Y/N)
ER+ and/or PgR+
Location of recurrence
(breast vs Mx scar/
chest wall vs regional
lymph nodes)
R
A
N
D
O
M
I
S
A
T
I
O
N
A
B
observation
(± RT)
ER+ and/or PgR+:
endocrine therapy
HER2+:
trastuzumab
(optional)
CT
(± RT)
ER+ and/or PgR+:
endocrine therapy
HER2+:
trastuzumab
(optional)
mandatory for ER and/or PgR receptor-positive recurrent tumours.
at discretion of investigator. Must be at least 3 cycles and should start within 4 weeks
of randomisation and within 16 weeks of resection of loco-regional recurrence.
recommended for patients who have not received prior adjuvant RT. Patients with microscopically involved margins of resection must receive RT of ≥ 40 Gy. Patients randomised to CT should receive RT before, during or at the completion of CT. For all patients, RT must begin within 9 months of surgery.
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 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 early occurrence of menopausal symptoms (hot
flushes, mood changes, early bone changes and heart disease), many patients in this group also wish to
prevent infertility as a result of 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 endocrine non-responsive 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.
The ANZ BCTG has enrolled 36 of the 169 patients participating in this trial internationally (31 March 2009).
Lead International Group: The Southwest Oncology Group (SWOG) and International Breast Cancer Study Group (IBCSG)
ANZ BCTG Study Chair: Assoc Prof Kelly-Anne Phillips
(Peter MacCallum Cancer Centre)
29 September 2006
Patient Population
Stratification
Premenopausal
≥ 18 < 50 years
Age: < 40 vs 40-49
Stage I, II or IIIA
breast cancer
(neo)adjuvant
chemotherapy regimen:
4 cycles vs 6-8 cycles
anthracycline based
regimen vs 6-8 cycles
non-anthracycline
based regimen
ER- and PR-
Radiotherapy:
Goserelin:
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.
31
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, hormone treatment
usually consists of an aromatase inhibitor such as letrozole. 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. Results from some smaller studies indicate that short breaks from letrozole
treatment may make letrozole-resistant breast cancer cells more vulnerable to letrozole treatment when
the treatment is restarted.
The international trial SOLE, is evaluating whether having three-month treatment-free periods, during five
years of extended letrozole treatment, will further prevent or delay breast cancer from returning.
This trial is being opened progressively at ANZ BCTG participating institutions and the number enrolled
is expected to increase over the next 12 months. The ANZ BCTG has enrolled five of the 425 patients
participating in this trial internationally (31 March 2009).
ANZ BCTG Study Chair: Dr Jacquie Chirgwin (Box Hill and Maroondah Hospitals)
19 February 2009
Patient Population
Stratification
Postmenopausal
Institution
ER and/or PgR+
early BC
4-6 years of prior AET
therapy
Node-positive at initial
diagnosis
Prior AET
(AI(s) SERM(s)):
AI alone, SERM alone,
both SERM and AI
*
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
LET:
letrozole 2.5 mg daily po for 5 years of adjuvant therapy
Intermittent LET: 2.5 mg daily po for the first 9 months of years 1 through 4, followed by 12 months in year 5
AET:
adjuvant endocrine therapy
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.
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.
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, close to half the women with HER2-positive
breast cancer treated with trastuzumab may still have a recurrence of their disease some years later, so
new and more effective therapies need to be investigated.
Lapatinib is a new oral 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.
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 patients will receive treatment for 12 months. Some patients may also
receive chemotherapy with a taxane for the first 12 weeks of treatment if their oncologist thinks this is
indicated.
For the first time we have a truly global trial as it involves collaboration with research groups from North
America, Europe and the ANZ BCTG all working together. This is the first such collaboration for an
adjuvant study and it will help to provide reliable results at the earliest opportunity.
ALTTO is the single most important trial being conducted for women with HER2-positive breast cancer.
If treatment with lapatinib alone, or in combination with trastuzumab is more effective than trastuzumab
alone, the outcome for these women will be improved.
A substudy investigating women’s preferences for the different modalities of therapy is under
development.
The ANZ BCTG has enrolled 97 of the 4,681 patients participating in this trial internationally
(31 March 2009).
33
Breast International Group (BIG)
ANZ BCTG Study Chair: Assoc Prof Fran Boyle (Mater Sydney)
ANZ BCTG Study Co-Chair: Dr Marion Kuper-Hommel (Waikato Hospital, NZ)
15 April 2008
Patient
Population
S
U
R
G
E
R
Y
Stratification
Completely
excised HER2positive invasive
breast cancer
(Neo)adjuvant
anthracyclinebased
chemotherapy
completed
(≥ 4 cycles)
Hormone
receptor status
known
CT timing
ER and/or PgR
positive vs
negative
Lymph nodes
not assessed
(neoadjuvant
chemotherapy)
vs 1-3
vs ≥ 4 positive
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
1500 mg po daily
Sequential
weeks → 6 week washout → lapatinib
1500 mg po daily for 34 weeks
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
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
Consumer Advisory Panel Report
The ANZ BCTG has led the way in forming partnerships with women whose lives have been affected by
breast cancer and in acknowledging their valuable contributions to research and the breast cancer cause.
In 1999, the Board of Directors established a Consumer Advisory Panel (CAP) to provide a consumer
perspective to the ANZ BCTG research program, particularly in the area of Patient Information and Consent
materials. Today, all clinical trial protocols and relevant research documents are reviewed by the CAP using
guidelines developed jointly by the CAP and the ANZ BCTG.
CAP members represent the interests of all women with breast cancer, and in particular, those women who
have, or who are currently participating in an ANZ BCTG clinical trial. CAP members met four times over the
reporting period to discuss and plan activities.
Clinical Trials Activities
Consumer input to clinical trial protocols has proven to be very beneficial, helping to develop improved
patient materials providing more clarity and understanding for potential new clinical trial participants.
Strategies are in place which encourage discussion and feedback between the CAP and researchers
regarding each reviewed document. During the reporting period, CAP members reviewed three clinical trial
protocols and provided feedback on Patient Information and Consent materials.
The CAP also firmly believes in Quality of Life measures for appropriate clinical trials and together with the
researchers of the ANZ BCTG, the CAP has helped to ensure these are an important component to the
development of new clinical trials.
Membership
CAP members during the reporting period were: Professor Linda Reaby AM, Jennifer Bryce, Sheryl Fewster,
Cheryl Grant, Sue Guthrie, Carol Whiteside and Leonie Young.
Linda Reaby, Chair of CAP, took a leave of absence commencing November 2008. The Chair position has
been shared by fellow CAP members Cheryl Grant and Leonie Young.
CAP members are active in the following ANZ BCTG committees and external committees:
■■
Linda Reaby: Steering Committees of ANZ 0501 LATER, IBIS-II, ANZ 0502 (Neo-Gem); Scientific
Advisory Committee.
■■
Jennifer Bryce: Scientific Advisory Committee, Local Therapy Sub-committee.
■■
Sheryl Fewster: Supportive Care Sub-committee.
■■
Cheryl Grant: Systemic Therapy Sub-committee; Patient representative for Australasia: ALTTO
International Steering Committee; Associate Investigator on a grant application for a proposed study:
PANZ-ALTTO Sub-study Investigation of Patient Preferences.
■■
eonie Young: Associate Investigator on a grant application for a proposed study - Physical Activity
L
and Breast Cancer Survivorship: A program of Research on Survival, Quality of Life and Associated
Mechanisms – an international collaboration; and SNAC I and II Steering Committees.
CAP members have helped the ANZ BCTG senior management to develop a CAP Terms of
Reference (TOR) to act as a guiding document for all CAP activities. The TOR includes
the purpose, guiding principles and role of CAP, along with information
regarding membership, governance and resources.
35
Advocacy Activities
CAP activities extend beyond clinical trial protocol review, with its members actively involved in creating
awareness and understanding of clinical trials via public speaking opportunities, presentations at
conferences (both national and international), co-authoring of scientific papers and other publications,
conduct of media interviews and consumer forums.
Leonie Young represented the ANZ BCTG CAP at the NBCC International Clinical Trials Project LEAD in
Paris in December 2008.
The CAP assists with IMPACT - Improving Participation and Advocacy for Clinical Trials - which is a unique
ANZ BCTG initiative to create a network of women who have been ANZ BCTG clinical trial participants.
The CAP firmly believes that women who have experienced first-hand what it is like to participate on a
clinical trial are well placed to promulgate the importance of clinical trials and the benefits for women. Thus,
all components of the IMPACT Program are designed to ensure members are well equipped and able to
advocate effectively for clinical trials research in their communities.
A component to IMPACT is the IMPACT Advocate Program in which CAP members play a lead role in
coordination and mentoring. This program is held in conjunction with the ANZ BCTG Annual Scientific
Meeting and is an innovative way to provide a select group of consumers with a unique insight into the
breast cancer clinical trials research process. In 2008, the program included advocates from New Zealand,
New South Wales, the Australian Capital Territory and the Northern Territory. We are very grateful for the
support of Associate Professor Ian Campbell, Dr Nicole McCarthy and Dr Jacquie Chirgwin who gave their
time to lead the daily tutorial sessions. We were also particularly delighted to have a presentation by Margo
Michaels, Director and Founder of the Education Network to Advance Cancer Clinical Trials. This is a United
States organisation devoted to community centred approaches to cancer clinical trials education. Margo
shared with us some of her approaches to expanding consumer influence in cancer clinical trials.
The future
The ANZ BCTG was one of the first clinical trials research groups to involve consumers in the planning and
conduct of its research program. CAP members bring extensive and valuable connections with key breast
cancer organisations and personal experience to their role, but each participates in the ANZ BCTG CAP
as an independent consumer. CAP members bring the views of women to the table without constraint and
provide a unique and important perspective to the research programs of the ANZ BCTG.
The CAP is successful because its members have a mutual respect for each other’s beliefs and opinions.
The ANZ BCTG and its CAP have fostered an attitude of collaboration built upon acceptance, sharing of
information, and the desire to make a difference. This environment of collaboration and respect has been
nurtured by researchers and consumers alike. It is fundamental to the ANZ BCTG’s goal of delivering benefits
to women diagnosed with, or at risk of, breast cancer through the conduct of high quality clinical trials.
Leonie Young
Acting Chair
Consumer Advisory Panel
Cheryl Grant
Acting Chair
Consumer Advisory Panel
Fundraising and Education Report
The generosity of the Australian community continues to support the important work of the ANZ BCTG
via its fundraising and education department, the Breast Cancer Institute of Australia (BCIA).
I am delighted to report that the BCIA has had its most successful fundraising year to date, raising
$4.85 million from donations, corporate support and special events and projects. This increase has been
achieved whilst also keeping our costs to fundraise at a minimum (26%).
Income
Expenditure
Net Profit
$4,856,949
(11% increase on previous year)
$1,266,276
$3,590,673
(8.6% increase on previous year)
■■ Fundraising income does not include income from bequests ($55,000).
Operational Improvements
Over the past year, the BCIA has put into place several operational strategies to ensure the future
growth and success of our fundraising activities. These have included a restructure of the Donations
Processing Department, the employment of new staff and a reassignment of particular duties within
current staff portfolios.
Ongoing development of our website, specifically the online donation facility, has been a priority and
an investment was made to purchase the software programming modules of our fundraising database.
This has provided us with new opportunities to develop and enhance our database and to assist in
decreasing the costs and response times associated with processing donations.
Fundraising
The “journey” our donors experience when they choose to support the BCIA is very important. Our
intention is to build strong, engaging relationships over the long term and to ensure our donors receive
the best possible attention and acknowledgment for their support, and the assurance that each
donation is used wisely.
To this end, our “donor journey” is continually being developed and refined as we respond to the
individual needs of our donors. We are exploring new ways to contact donors, and we hope to learn
more about those who support us by conducting special surveys over the coming 18 months.
We have spent time consolidating our existing long term corporate relationships and working on
new ways to enhance these relationships. We want to ensure these partnerships remain relevant
and mutually beneficial. The wonderful generosity of Avon, its Sales Representatives and customers
continues with the recent donation of $500,000. We are so grateful for their efforts on our behalf.
37
So too, our partnership with the Commonwealth Bank continues to grow as we identify new ways of
working together to promote our Australian Women’s Health Diary. The Bank, its staff and customers
continue to support the diary very generously and the many unique opportunities the Bank provides to
us to promote our research is very much appreciated.
One of the highlights of the year has been the success of our 2009 Australian Women’s Health Diary
which raised net $867,000 and achieved a 91% sales rate. We are delighted to have a loyal customer
base which keeps on growing and extend our thanks to every person who purchased a diary. The team
at The Australian Women’s Weekly remain committed to continually improving each new edition of the
diary – no easy feat and yet always achieved! I am sincerely grateful to Jo Wiles, Deputy Editor of The
Weekly, for her unfaltering commitment to this project.
Education
An important role of the BCIA is to facilitate knowledge and understanding of clinical trials research in
the wider community. A recent highlight has been the expansion of the IMPACT Program to include
women from New Zealand who have participated in an ANZ BCTG clinical trial. In addition, the facility
to join IMPACT online via the BCIA website has proven successful with many women, particularly from
New Zealand, joining IMPACT this way.
In Summary
Our fundraising and education successes over the past year have been very much a team effort. I am
fortunate to work with very dedicated and motivated people who are committed to the cause and to
their own professional development. I congratulate the BCIA staff on the results we have achieved this
year and thank them for their efforts.
Funds raised by the BCIA are crucial to ensuring ANZ BCTG researchers can pursue new research ideas
at the earliest opportunity which in turn provides benefits to women who face this disease each day.
Consumer advocacy activities are also important to create greater understanding and awareness of the
clinical trials process and the benefits of this research for women.
It is certainly a privilege and very humbling to experience first-hand the generosity of our community
at large. Giving is for many a very personal experience and at times even more remarkable when you
consider it is often at a time of extreme loss and heartbreak.
My thanks extend to the many thousands of individual donors, community groups and clubs, small and
large businesses, schools and well-known corporate identities. Please be assured your ongoing support
for the ANZ BCTG research program is very much appreciated and highly valued.
Julie Callaghan
General Manager
Fundraising Achievements and Highlights
Donations
Engagement of our regular donors remains a high priority for the BCIA. New ways of communication
with our donors and the timing of mail campaigns has together assisted in increasing income from
donations by 6% from the previous financial year.
Over the past five years, gross income from donations has increased by 48%.
2005
2006
2007
2008
2009
$1,920,787
$2,113,600
$2,267,499
$2,680,075
$2,844,488
Appeals
Four appeals were conducted during the reporting period
along with our special Certificate Mailing recognising the
giving history of our donors.
Two of these appeals included our bi-annual newsletter
(Editions 20 and 21) which keeps our donors up to
date with research progress and reports on fundraising
activities. The newsletter is also available via our website.
Regular Giving Program
Membership of our Regular Giving Program has grown with many donors now committing to a
regular, monthly donation. Regular giving to the BCIA helps to ensure continuity of our research
programs and enables us to plan ahead to take advantage of new research opportunities. It also
significantly decreases our administrative costs and for many of our donors it makes giving “easy”.
New donors
It is important to continually attract and secure new long term donors to our
research programs.
The 2008 Mother’s Day Research Appeal achieved enormous
growth thanks to the support of the advertising agency Lowe
and the media company Universal McCann. More than
3,400 people made a donation in lieu of a gift for Mother’s
Day and each received a special Mother’s Day Card to give
to their mother or someone special which acknowledged
their donation. This campaign generated record income and
acquired many new donors to the BCIA.
39
Our National Breast Cancer Awareness
Month Mail Campaign conducted in October
2008 featured the story of Sheryl Fewster, a
breast cancer survivor and member of our
Consumer Advisory Panel. Many thousands
of people throughout Australia responded
to Sheryl’s personal story of her strong family
history of breast cancer and subsequent
diagnosis.
Sheryl Fewster with her family.
Bequests
Bequests are a very important source of funding for the BCIA. Through our Bequest Program we
provide regular information and advice to existing donors, potential new bequestors, solicitors and other
relevant legal publications.
During the reporting period two bequests were received and we gratefully acknowledge the
following:
■■
Estate of the late Stanley Spencer Docker
■■
Estate of the late Thelma May Towell
In Memoriam
Giving a gift when a friend or family member dies is a meaningful and lasting way of commemorating
their life and supporting breast cancer research.
The BCIA received many In Memoriam donations during the past financial year. Our In Memoriam
literature and donation envelopes were also sent upon request to relatives and Funeral Homes
throughout the year.
We sincerely acknowledge donations made in memory of:
Ms Beryl Abberton
Ms Janis Broalridje
Ms Ellen Cook
Ms Constance Adams
Ms Pam Broalridje
Ms Marie Cookson
Mrs Alla Andrivon
Ms Olive Burchell
Mrs Gina Cooper
Mrs Kim Avard
Ms Brenda Camisa
Ms Joan Cord-Udy
Ms June Bailey
Mr Stephen Carlson
Mrs Shelly Louise Cox
Mrs Janice Banff
Mrs Jan Cassar
Ms Dulcie Craig
Mrs Sharyn Barclay
Ms Nagammal Chetty
Ms Palma Cressotti
Mrs Taita Beaven
Mrs Helen Chu (nee Little)
Mrs Arecia D’Albret
Mrs Helen Bendall
Mrs Carole Clark
Mr Clem Davies
Ms Judy Birt
Ms Kendelle Clark
Dawn and Ruby
Ms Margaret Black
Mrs Irene Clarke
Ms Elizabeth Dawson
Mrs Veronica Blignaut
Mrs Cathy Clifford
Mrs Joan Dixon
Mrs Alicia Boyle
Ms Betty Cohen
Mrs Joanne Duff
Mrs Rena Breddin
Mrs Amelia Cook
Ms Jean Helen Earkins
Ms Corinne Rose Elyard
Mrs Lucia Loren
Mrs Shirley Sale
Ms Janis Evans
Mrs Angela Ludowici
Mrs Carol Sbiza
Ms Pam Evans
Mrs Margaret Seger
Ms Maggie Fairweather
Mrs Alison Rosemary
MacDonald
Ms Pam Farmer
Mrs June Magan
Ms Barbara Fisher
Ms Marion Mann
Mrs Laureen Smith
(nee Gabbett)
Mrs Michelle Fowler
Ms Merle Matson
Mrs Lorna Somers
Mrs Valda Franklin
Mrs Katie Mattner
Mrs Glenda Stewart
Mrs Jennifer Gabbett
Ms Kerryn McCann
Ms Jennifer Stone
Ms Sally Gillies
Ms Mary McFarlane
Mrs Clare Stone
Mrs Andy Grant
Mrs Jane McGrath
Mrs Bessie Janet Stracey
Mrs Anne-Marie Groves
Mrs Anna McIlwain
Ms Rosemary Sutherland
Mrs Francesca Gwyther
Mrs Marian McKerrigan
Mrs Valerie Tepper
Ms Georgina Hart
Ms June Megan
Ms Debbie Thompson
Mrs Jean Hawkins
Ms Susan Meredith
Mrs Ingrid Todd
Ms Petra Henn
Mrs Merrilyn Minter
Mrs Sue Todner
Ms Brenda Hertogs
Mrs Virginia Money
Ms Ninette Trent
Mrs Marion Hilleard
Miss Ruth Morgan
Ms Julie Turner
Mrs Marlie Holding
Mrs Paula Murphy
Mrs Linda Ward
Ms Roslyn Hunter
Mrs Patricia Natt
Mrs Karyn Warren
Mrs Kathryn Inglis
Ms Jean Newton
Mrs Connie Webb
Mrs Jo Iveson
Mrs Marilyn O’Brien
Mrs Eve Wilcher
Ms Elizabeth Johnston
Ms Patricia Pandos
Mrs Mary (Mollie) Wilks
Mrs Joyce Johnstone (Evans)
Ms Nora Gertrude Parker
Ms Lyn Williams
Mrs Violet Johnston
Mrs Dawn Pearson
Chris Wilmot
Mrs Judy (Janice) Jones
Mrs Marcia Gwendelyn Perrett
Mr J H Wilson
Mrs Kath Keeping
Ms Margaret Peters
Ms Kylie Jane Withers
Mrs Joan Kennedy
Ms Denise Peterson
Ms Winnie Wong
Mrs Margaret Ann Kentler
Mr D Petsas
Mrs Pam Woods
Mr Sammy Keramas
Mrs Violet Ethel Phillips
Mrs Maureen Yates
Mrs Lynne Kidred
Ms Dorothy Porter
Mr Peter Zachariassen
Mrs Kylie Margaret King
Mr Walter Price
Mrs Lyn Zachariassen
Mrs Dorothy Laughlin
Mrs Gaye Prior
Mr Barrie Laughnan
Mrs Lynette Ravelli
Mrs Jean Leeson
Ms Shirley Lorraine Reed (Mills)
Mrs Denise Lindsay
Mrs Patricia Russell
Mrs Jean Littlewood
Ms Debbie Ryan
Mrs Gaye Loesch
Mrs Joan Salamy
Ms Karen Shanks
41
In Celebration
Many committed donors conducted In Celebration events in lieu of gifts for special occasions
throughout the past financial year. Our In Celebration packs were highly sought after as individuals chose
to celebrate their birthdays, weddings and other special events in a truly “giving” way.
We acknowledge the following donors for their generosity:
Mrs Margaret Ashton
80th Birthday
Mr and Mrs Brian Barnes
Retirement
Mrs Narelle Beattie
Birthday
Mr and Mrs Jack Bonotto
40th Wedding Anniversary
Ms Carol Carmichael
60th Birthday
Ms Jocelyn Chenu
60th Birthday
Mrs Valerie Chick
75th Birthday
Mrs Rosemary Coghlan
60th Birthday
Mr Barry Crowe
Birthday
Mr and Mrs John Difford
Ms Helen Donovan
Birthday
Mr Shane Duncan
50th Birthday
Mrs Sue Flanigan
Christmas
Ms Emma Flynn
Christmas
Mrs Melissa Greaves
Birthday
Mrs Ethel Gregg
Christmas
Mrs Claire Grover
60th Birthday
Ms Sheila Hargrave
70th Birthday
Dr Lillian Hayes
60th Birthday
Ms Lyn Hill
50th Birthday
Ms Jocelyn Honour
Christmas
Mr and Mrs Scott and Kirsty Hutchinson
Wedding
Mrs Dorothy Kerr
Birthday
Mrs Beth King
60th Birthday
Mrs Dorit Krawitz
70th Birthday
Mr and Mrs Ron and Margaret Lawrence
Mr Greig Lawrie
70th Birthday
Mrs Kaye McGuffie
50th Birthday
Mr and Mrs Steve and Sasha McHardy
Wedding
Mrs Christine McKenzie
Birthday
Mrs Marj McLeod
Christmas
Mr Darcy Melrose Hodgson
Birthday
Ms Cathy Miller
Birthday
Mrs Karen Ng
60th Birthday
Mrs Judy Opit
70th Birthday
Mrs Helen Owens
60th Birthday
Mr Russell Patrick
50th Birthday
Mr and Mrs N Peace Golden Wedding Anniversary
Mrs Marina Perera
Christmas
Mrs Dhineli Perera
Christmas
Ms Margaret Peters
50th Birthday
Ms Liz Phillips
50th Birthday
Miss Danielle Probyn
23rd Birthday
Mr Jon Roberts
Christmas
Mrs Laurel Rowe
Christmas
Mrs Rose Simon
51st Birthday
Mrs Nina Stillone
Christmas
Mrs Alana Sutcliffe
Birthday
Online Activity
The BCIA website continues to provide information and opportunities to engage our donors and the
wider community. We strive to ensure the information on our website is up to date and relevant so that
visiting our site is an enjoyable and unique experience.
Fundraising activity on the website during the past financial year is shown below.
Merchandise purchases
Registration for Avon race for research
Donations received from existing donors
Donations received from new donors
43
Special Events and Projects
Special events and projects are important activities for the BCIA. As well as generating essential income,
many of our special events and projects provide a unique opportunity for the BCIA to promote the
ANZ BCTG research program, often on a large scale and to many different audiences.
Income from special events and projects has increased in the past financial year by 25%. We are
pleased with this result which stems from increased activity in this area, along with higher revenue
generated from some of our long term projects.
Over the past five years, gross income from special events and projects has increased by 79%.
2005
2006
2007
2008
2009
$807,879
$877,193
$915,997
$1,154,075
$1,445,927
Australian Women’s Health Diary
The Australian Women’s Health Diary is a unique project of the BCIA which first
came to life in 1999. The intention was to create an ongoing source of funding
for the ANZ BCTG research programs and to provide a useful and informative
tool for women of all ages to assist in their general health and wellbeing. The
fantastic response we receive each year to our diary from the community
confirms that this diary continues to achieve these aims. We are committed to
ensuring our diary continues to be relevant, informative and an essential item
for both our existing, and potential new customers.
The 2009 Australian Women’s Health Diary has been our most successful edition generating a net profit
of $867,000, an increase of 22% on the 2008 edition. We have achieved a sales rate of 91% across
all selling channels. This brings the total raised from the diary since the first edition in 1999 to net $5.1
million. This is a critical contribution to the success of our ongoing research programs.
Special thanks go to our long term, committed sponsors - The Australian Women’s Weekly which
produces the diary on our behalf, the Commonwealth Bank which also sells the diary to Bank
staff and the general public, and Avon. We are also grateful for the personal support Chris Bath
(pictured), Channel 7 news anchor, continues to give to our diary and research programs.
Celebrating 10 years
In August 2008, we were fortunate to gather together many of those people and sponsors instrumental in
the development and success of our diary over the past 10 years. A special dinner was held and those in
attendance were given an inspiring update on our research progress and what has been achieved thanks to
monies raised by our ongoing fundraising efforts, in particular from the diary.
Representatives from our major sponsors and key individuals involved in producing the diary were
presented with framed certificates showing all 10 covers of the diary.
Anthony Dene, Avon; John Forbes, BCIA;
Jo Wiles, The Australian Women’s Weekly;
Adrianne Nixon, Lowe.
Darlene Gill, Rosemary Bruce, Meegan Davies, Sharon
Brown, Stephanie Osfield and Phil Napper who have all
worked on the diary pictured with John Forbes.
Deborah Thomas, The Australian
Women’s Weekly; Dr Jacquie Chirgwin,
ANZ BCTG Board Chairman; Poppy
Fassos, Commonwealth Bank.
45
Macquarie Links Golf Club, Sydney NSW
Charlestown Golf Club, NSW.
Tee Off for Breast Cancer Research
This event continues to be well supported by golf clubs throughout Australia
with 320 clubs participating in the 2008 event helping to raise a record
$140,000. This represents a 33% increase in income from the 2007 event.
Golf clubs nominate a day, or a number of days, in their event calendar to
Tee Off for Breast Cancer Research. The format of the day is up to each
club and many innovative ideas from clubs and their members this year
contributed to the overall enjoyment and success of their events.
Shortland Waters Golf Club, NSW
Ladies at Easts Leisure and Golf Club NSW held a bromeliad auction and
members of Mount Coolum Golf Club QLD got into the spirit of the event
by offering a pink nail painting service to all golfers on the day. The creative
flair of the ladies at Wauchope Golf Club NSW caused quite a stir in the golf
community when the greens people found a bra and balloon “fence” on the
first tee of their golf course!
We congratulate the following clubs who were particularly successful
in their 2008 events:
Macquarie Links International Golf Club, NSW
$10,240
Wynnum Golf Club, QLD
$6,550
King Island Golf Club, TAS
$6,233
The Vintage Golf Club, NSW
$5,108
Sussex Inlet Golf Club, NSW
$4,800
Richmond Golf Club, NSW
$4,600
Alyangula Golf Club, NT
$3,913
Hervey Bay Golf Club, QLD
Mt Coolum Golf Club, QLD
Hervey Bay Golf
Club, QLD
Mt Coolum golfers get into the spirit
Avon race for research
Our 5km fun run and walk, Avon race for research, surpassed all
expectations in 2008 attracting a record 3,380 entrants and raising a
remarkable $94,000 for the BCIA. This represents a 42% increase in
income and a 47% increase in participation from the 2007 event.
Held on 26 October 2008 on the Newcastle Foreshore NSW, it was the
most successful in the 12 year history of the race and brings the total
monies raised from this event to $440,000.
The online entry component proved to be very successful with a third of all
entrants utilising this facility. A record number of entrants also registered
for the Newcastle Permanent Sponsorship Challenge, which 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.
The introduction of timing chips was well received by all entrants and
helped to streamline the registration process and time recording on the
day. The technology the timing chips provided also contributed to a
significant reduction in the cost and resources required to produce the
post-race certificates acknowledging entrants’ participation, time and
place within their chosen category.
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.
Avon generously provided a free Sunscreen and Lip Balm for every
entrant who crossed the finish line. Our special thanks also go to
our other major sponsors: Newcastle Permanent, The Herald, Radio
Newcastle NXFM and Southern Cross Ten.
47
Community Fundraising
We are continually overwhelmed by the generosity and energy of the Australian community. The BCIA
is fortunate to be regularly approached by individuals, community groups and clubs, schools and
businesses to be the recipient of funds raised via special events they wish to conduct on our behalf.
Our Fundraising Guidelines and Application Form is supplied and authorities issued to govern these
important relationships.
We are particularly grateful to the following who have raised essential funding for our research
over the past year:
ACE Radio Broadcasters, Horsham VIC
Allianz Australia, Charlestown NSW
Belcastro Hair, Northmead NSW
Belmont Hospital STRAS Unit, Belmont NSW
Bev Powell and Barb Withers, Wagga Wagga NSW
Billie Bowen, Charters Towers QLD
Black Lotus Yoga Studios, Enmore NSW
BNC Netball Club, Merewether NSW
Brunkerville Uniting Church, Brunkerville NSW
Church of the Good Shepherd Handcraft Group, Kotara South NSW
Dean Cook, Williamtown NSW
Doug Wiskins and Joyce Workman, Pelaw Main NSW
Grand Court of NSW Order of the Amaranth, Toukley NSW
Gresford Women’s Bowling Club, East Gresford NSW
Ivan Webster, Vermont VIC (pictured)
Joanne Meehan, Castle Hill NSW
Kay Wahlstedt, Cardiff NSW
Leo’s Takeaway, Raymond Terrace NSW
Maitland Embroiderers Incorporated, Maitland NSW
Ivan Webster shaved his beard of 37 years to
raise funds for the BCIA.
Maitland Patchwork Quilters
The cheque presentation from the NSW Police
Force Spokeswomen’s Network.
Maitland Patchwork Quilters, Maitland NSW (pictured)
Maureen Kelly, North Arm Cove NSW
Milton College, North Sydney NSW
Narla Village Aged Care Facility, Belmont North NSW
New South Wales Police Force Spokeswomen’s Network,
Parramatta NSW (pictured)
North Shore Primary School, Geelong VIC
Quorn Bowling Club, Quorn SA
Palm Lakes Resort Social Club, Carindale QLD
Patrons of the Sacred Heart Housie, Newcastle NSW
Peta Allman, Roseville NSW
Rachel Wadsworth, Goughs Bay VIC
St Joseph’s Craft Group, North Mackay QLD
St Phillip’s Christian College, Waratah NSW
Sewing Bees, Salamander Bay NSW (pictured)
Shoukash Jewellery, Granville NSW
South of the River Hairdressing, Adamstown NSW
Stockton Women’s Bowling Club, Stockton NSW
Swansea Football Club, Swansea NSW (pictured)
Swansea Workers Club, Swansea NSW
Telstra Business Services, Southbank VIC
The Trinity Connection, Summer Hill NSW
Thompsons Australia, Hurstville NSW
Trish Price, Palmwoods QLD
Uproar Ladies Fashions, Belmont NSW
Varley Country Club, Newdegate WA
Woodlands Quilting Group, Wallsend NSW
Sewing Bees
Participants in the Swansea Football Club
fundraiser.
49
Corporate Support
The BCIA is fortunate to receive ongoing support from a number of well-known corporate organisations.
Our partnerships with these corporate organisations are successful and rewarding and each has been
long term. This demonstrates the special ongoing commitment these corporate organisations share with
us to save lives and bring health benefits to all Australians.
Income from corporate organisations has increased by 4% from the previous year. This modest growth is
reflective of our recent strategies to consolidate and build on our existing relationships. It is important to build
corporate partnerships which are vibrant, successful and mutually beneficial to all involved.
2005
2006
2007
2008
2009
$561,400
$560,109
$553,466
$544,887
$566,534
■■ This income does not include sponsorship received from the Commonwealth Bank for the Australian Women’s
Health Diary. This is represented in the Special Events and Projects income.
Avon
We are delighted to have been in partnership with Avon Australia, its Sales Representatives and clients
since 1996. Since this time, Avon has donated a remarkable $5.85 million to our research programs
through the sale of Avon Pink Ribbon Products.
Avon Sales Representatives do not make any profit from the sale of Pink Ribbon Products – all of the
monies raised are donated to the breast cancer cause – and this makes them very special members of
our research team.
Avon Public Relations Manager, Ms Michaela Groves, presented Professor John Forbes, ANZ BCTG Director
of Research, with a donation of $500,000 at the 2008 Avon race for research event (pictured below). These
funds were raised by the sale of the Avon Pink Ribbon Key Ring and Charm Bracelet (pictured).
Avon race for research, a 5km fun run/walk in Newcastle NSW, is sponsored by Avon and in 2008 more
than 3,380 people received a free Avon Sunscreen and Lip Balm when they crossed the line.
Avon also supports our efforts to foster and attract the best, new breast cancer researchers by
sponsoring the Avon Travel Grant which provides opportunities for breast cancer researchers from
throughout Australia to attend the Annual Scientific Meeting (ASM) of the ANZ BCTG. Eleven grants
were awarded in July 2008 to attend the ASM in Wellington, New Zealand and each recipient was very
grateful for the opportunity to attend this important research forum.
Avon is also a sponsor of our Australian Women’s Health Diary and in September 2008, Avon joined with
the Commonwealth Bank to provide a special incentive to Bank staff to purchase the 2008 edition. For
each Bank staff purchase, Avon provided a free mascara. The campaign was an overwhelming success.
Commonwealth Bank
The Commonwealth Bank has shared a special partnership with the BCIA since 1995 helping to raise
$1.4 million for the ANZ BCTG research programs.
The Commonwealth Bank sponsors the production of the Australian Women’s Health Diary and provides
essential support in promoting the diary to its staff, customers and the general community.
Bank staff support the diary and in 2008 purchased more than 6,500 of the 2009 edition, an increase
of 1,000 from the previous year. These sales generated $52,000 and the Bank matched every purchase
with an additional $1.00 donation, bringing the total raised by Bank staff to $59,000.
Over the past 11 years, the combination of Bank staff sales and the Bank’s matching dollar program has
generated $437,000 for our research programs.
In 2007, the Bank sold the diary in selected branches nationally for the first time. Thanks to the Bank’s
continued support, diaries were again available at selected Commonwealth Bank branches around
Australia from October 2008 until January 2009. Bank branches sold over 5,460 copies of the 2009
edition, an increase of 44% on the previous year.
During October 2008, Commonwealth Bank staff organised pink-themed events at branches throughout
Australia, raising more than $5,400 from their efforts.
As part of the 2009 Commonwealth Bank Cricket Series, the Hitting Cancer for Six initiative, now in its
third year, saw the Bank donate $1,000 for every six hit by the Australian and South African players.
The total amount raised was $45,000 and we were delighted to share this with the Prostate Cancer
Foundation of Australia (PCFA).
Pictured with Mike Hussey are Associate
Professor Fran Boyle, ANZ BCTG Board
Member and Mr Andrew Giles, CEO of the
PCFA.
51
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.
We are very fortunate to have a wonderful team led by Jo Wiles, Deputy Editor of The Weekly, helping
to produce our diary. Many of the team, including Jo, have worked on every edition. Their expertise in
writing, researching, editing, designing, promoting, producing and distributing the diary is the key to our
diary’s great success.
Other valued corporate sponsors include Mary Kay, Lowe, The Toner Recycler and
Dateline Imports.
Mary Kay Cosmetics has conducted the Warm Fuzzy Campaign since 1991. Mary Kay Directors and
Consultants sell pink, fluffy Warm Fuzzies with antennae, big eyes and big feet for a gold coin donation.
Mary Kay has raised over $394,000 from this initiative.
Lowe is a valuable supporter of our research programs, having provided pro bono advertising advice
for many of our fundraising campaigns for more than 10 years. Lowe helped to secure the support
of Universal McCann for our 2008 Mother’s Day Campaign. The increased media exposure Universal
McCann was able to obtain made this our most successful Mother’s Day Campaign to date.
The Toner Recyler Pty Ltd specialises in the collection and distribution of empty printer and fax toner
cartridges to the toner recycling industry. The BCIA receives $1.00 for every original toner cartridge
collected that can be remanufactured. The Toner Recycler has donated $132,000 since 2002 from this
initiative.
Dateline Imports specialises in importing hair care and beauty products from around the world. In 2006,
Dateline Imports launched a special range of Think Pink hair appliances and tweezers with $1.00 from
the sale of each product donated to the BCIA. Dateline Imports has donated $11,287 since 2006 from
this initiative.
Education Achievements and Highlights
The BCIA plays an active role in facilitating consumer involvement in, and awareness of, the research
programs of the ANZ BCTG. This includes facilitation of the Consumer Advisory Panel, management of
the IMPACT Program, coordination of public consumer forums and the promotion of research results
and other relevant information to the Australian and New Zealand public.
Highlights for the reporting period are summarised below.
IMPACT
IMPACT - Improving Participation and Advocacy for
Clinical Trials - is a program for women who have
participated in a clinical trial conducted by the ANZ BCTG
and acknowledges the contribution they have made to
breast cancer prevention and cure.
IMPACT aims to provide its members with reliable
information so that they may become effective advocates
for breast cancer clinical trials in the wider community.
IMPACT membership has grown with women from New Zealand joining in 2008. This brings the
membership to 1,700 women from all states and territories of Australia and New Zealand.
Recruitment to the program is primarily via the IMPACT Recruitment Brochure which is provided to
ANZ BCTG participating institutions to give to new clinical trial participants. Over 1,500 recruitment
brochures were distributed to institutions throughout Australia and New Zealand in February 2009.
The IMPACT Newsletter is produced specifically for IMPACT members to keep them informed of
research progress. Editions 12 and 13 of the IMPACT newsletter were distributed to the membership in
October 2008 and March 2009 respectively.
An Information Session for new IMPACT members from New Zealand was held in Hamilton, New
Zealand in June 2008. More than 50 women attended and they were acknowledged and thanked for
their participation in the ANZ BCTG research program. It was also a wonderful opportunity to meet other
women who have been through a similar experience and to hear about the latest in research progress.
IMPACT Advocate Program
The 3rd IMPACT Advocate Program
was held in July 2008 in conjunction with
the ANZ BCTG Annual Scientific Meeting
(ASM) in Wellington, New Zealand.
This program provides IMPACT members
with the opportunity to attend the ASM
where the latest worldwide research
results and activities are discussed.
2008 IMPACT Advocate Graduates (l-r)
Libby Burgess, Leslie Reilly, Penelope
Creak, Bethel Holley, Raewyn Calvert.
53
The aim of the IMPACT Advocate Program is to equip consumers with knowledge and understanding of
the breast cancer clinical trials research process in order to promulgate its importance in the control of
breast cancer.
Five IMPACT members, including two from New Zealand, were accepted to this program in 2008
and found the experience very rewarding. Tutorial Sessions were conducted each day by ANZ BCTG
researchers to help the Advocates to interpret and understand the scientific presentations.
Leonie Young (left) and Linda Reaby (right) present Bethel Holley
with a certificate acknowledging completion of the 2008 IMPACT
Advocate Program.
Associate Professor Ian Campbell leading discussion at an IMPACT
Advocate Tutorial Session.
Consumer Forums
The ANZ BCTG conducts a public forum in conjunction with its Annual Scientific Meeting each year.
In 2008, the ANZ BCTG joined with The Breast Cancer Aotearoa Coalition and the Cancer Society
Wellington to present a special public forum for women in New Zealand.
Over 100 women attended the forum on Saturday 5 July and learnt about the latest in research
advances from international and local experts.
Guest speakers included:
■■
Associate Professor Fran Boyle AM, Chair ANZ BCTG Scientific Advisory Committee
■■
Associate Professor Ian Campbell, Clinical Director, Breast Care Centre, Waikato Hospital, NZ
■■
Dr Carol Johnson, Radiation Oncologist, Wellington Blood and Cancer Centre, Wellington NZ
■■
s Margo Michaels, Executive Director and President, Education Network to Advance Cancer
M
Clinical Trials, Silver Spring US
■■
Professor Linda Reaby AM, Chair ANZ BCTG Consumer Advisory Panel
Other Promotions
The BCIA reported two research highlights to the Australian and New Zealand public during the
reporting period. The first was a report on some of the excellent research presentations given at the
ANZ BCTG ASM in Wellington New Zealand in July 2008. The second was a report on follow-up data
for the international trial BIG 1-98 / IBCSG 18-98, which involved the largest number of women from
Australia recruited to an international breast cancer treatment trial. The data was presented at the 31st
San Antonio Breast Cancer Symposium in San Antonio, Texas US in December 2008.
Governance and Footprint
The ANZ BCTG is a collaborative, national and international breast cancer clinical trials research group.
It has both independent registered company status and academic status. The organisational structure of
the ANZ BCTG reflects its corporate governance and operational areas of responsibility.
All research conducted by the ANZ BCTG is carried out according to National and International
Guidelines for Good Clinical Practice, the guidelines of the National Health and Medical Research
Council (including the NHMRC Statement on Ethical Conduct in Research Involving Humans), the ethical
approvals for our clinical trials, and applicable policies and regulations.
The ANZ BCTG offices are located in Newcastle NSW Australia.
Board of Directors
(31 March 2009)
Dr Jacquie Chirgwin
Dr Chirgwin was elected Chair of the ANZ BCTG Board of Directors in 2005
and first became a member of the Board in 2003. She is also a member
of the ANZ BCTG Scientific Advisory Committee and has had a long
commitment to clinical research spanning some 20 years. Dr Chirgwin is a
Medical Oncologist at Box Hill and Maroondah Hospitals in Victoria and has
helped to establish breast cancer clinical trial departments in these hospitals
along with the Breast Unit at Mercy Private Hospital in East Melbourne. She
is a member of many national and international cancer research bodies.
Professor Alan Coates AM
Professor Coates is a founding member of the ANZ BCTG and has been a
Board Director since 1991. He is Board Vice Chair and was the Chairman of
the ANZ BCTG Scientific Advisory Committee for 13 years. He is Co-Chairman
of the Scientific Committee of the International Breast Cancer Study Group
which is based in Bern, Switzerland. Professor Coates served as the first
Chief Executive Officer of The Cancer Council Australia from 1998 to 2006.
Professor Coates has a long and distinguished international and national
career in cancer research. He was awarded an AM in 2002 for services to
medicine in the field of oncology, particularly breast cancer.
Professor Stephen Ackland
Professor Ackland was elected to the ANZ BCTG Board of Directors in
2007 and is a member of the ANZ BCTG Scientific Advisory Committee. He
is a Medical Oncologist and Senior Staff Specialist in the Medical Oncology
Department of the Calvary Mater Newcastle. Professor Ackland is a Director
of the NSW Cancer Council, Editor of the Asia Pacific Journal of Clinical
Oncology and is a member of many national and international cancer
research bodies.
55
Associate Professor Fran Boyle AM
Associate Professor Boyle was elected to the ANZ BCTG Board of Directors
in 2001 and is the Chair of the ANZ BCTG Scientific Advisory Committee. 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 National Breast and Ovarian Cancer Centre and 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 awarded
an AM in 2008 for service to oncology as a researcher and clinician, particularly
in the treatment of breast and brain cancers, to medical education, and as a
contributor to professional organisations.
Associate Professor Ian Campbell
Associate Professor Campbell was elected to the ANZ BCTG Board of
Directors in 2001 as the Board’s New Zealand Representative. He is a
member of the ANZ BCTG Scientific Advisory Committee and Chair of the
Local Therapy Sub-committee. He is a Surgeon and Associate Professor of
Surgery with the Waikato Clinical School, University of Auckland. Associate
Professor Campbell is the Clinical Director of the Breast Care Centre at Waikato
Hospital in Hamilton; Chairman of the Waikato Breast Cancer Trust; and the
NZ Representative on the Breast Section of the Royal Australasian College
of Surgeons. He chaired the NZ Guidelines for Management of Early Breast
Cancer (published August 2009) and serves on a number of breast cancer trial
management or steering committees. He has a long standing commitment to
cancer control and in particular to clinical research in breast cancer.
Professor John Forbes
Professor Forbes is a founding member of the ANZ BCTG and has been
a Board Director since 1991. He is the Director of Research of the Group
and a member of the ANZ BCTG Scientific Advisory Committee. Professor
Forbes is also Professor of Surgical Oncology, University of Newcastle;
Director, Department of Surgical Oncology, Calvary Mater Newcastle;
and Medical Director, Breast Cancer Institute of Australia. He was the
Group Coordinator of the ANZ BCTG Operations Office from inception to
November 2007. He has had a lifetime commitment to the pursuit of quality
in research through careful planning and conduct of clinical trials and is a
member of many international trial steering committees, and other national
and international clinical research bodies.
* Retired from the Board in July 2008.
Associate Professor Anne Hamilton
Associate Professor Hamilton was elected to the ANZ BCTG Board of
Directors in 2005, and is a member of the ANZ BCTG Scientific Advisory
Committee, and Chair of the Finance and Audit sub-Committee. She is a
Senior Staff Specialist in Medical Oncology at the Sydney Cancer Centre,
Royal Prince Alfred Hospital, Sydney and Clinical Associate Professor at the
University of Sydney. Associate Professor Hamilton trained in Melbourne
before furthering her training overseas in Brussels and New York. For the
past 15 years she has focused her activities in the area of breast cancer,
conducting a familial breast cancer risk management clinic and treating
women with early and advanced disease.
Associate Professor Geoff Lindeman
Associate Professor Lindeman is a Clinician-Scientist elected to the
ANZ BCTG Board of Directors in 2003 and is also a member of the
ANZ BCTG Scientific Advisory Committee. He is a Medical Oncologist at
the Royal Melbourne Hospital where he heads the RMH Familial Cancer
Centre. Associate Professor Lindeman is Laboratory Head (NHMRC Senior
Research Fellow) of the Victorian Breast Cancer Research Consortium
Laboratory, Walter and Eliza Hall Institute of Medical Research, Melbourne
and Clinical Director of the ACRF Centre for Therapeutic Target Discovery.
He is a member of the kConFab Executive (a consortium studying hereditary
breast cancer) and a committee member to the Victorian Cancer Biobank (a
Tissue Bank for cancer research).
Professor John Simes
Professor Simes has been an ANZ BCTG Board Director since 1991. He is
Director of the ANZ BCTG Statistical Centre located at the NHMRC Clinical
Trials Centre and a member of the ANZ BCTG Scientific Advisory Committee.
Professor Simes is a practising 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
Clinical Trials Centre (CTC), where he is responsible for the CTC’s overall
research program, and is an NHMRC Senior Principal Research Fellow. He
sits on many international committees planning clinical trials in cancer and
cardiovascular disease and has research interests in clinical trial methods,
quality of life assessment and integrating trial evidence for better decision
making and individualised care.
57
Scientific Advisory Committee (SAC)
(31 March 2009)
Assoc Prof Frances Boyle AM Chair
Medical Oncologist
Prof John F Forbes Vice Chair, ANZ BCTG Director of Research
Surgical Oncologist
Assoc Prof Ian Campbell Chair, SAC Local Therapy Sub-committee
Surgical Oncologist Prof Madeleine King Co-Chair, SAC Supportive Care Sub-committee
Psycho-Oncologist
Dr Nicole McCarthy Chair, SAC Systemic Therapy Sub-committee
Medical Oncologist
Dr Robert Brown Pathologist
Dr Jennifer Bryce
ANZ BCTG Consumer Advisory Panel
Dr Jacquie Chirgwin Medical Oncologist Assoc Prof Boon Chua Radiation Oncologist
Prof Alan Coates AM Medical Oncologist Prof John Collins Surgical Oncologist
Dr Prue Francis Medical Oncologist
Prof Val Gebski ANZ BCTG Group Statistician
Assoc 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
Assoc Prof Geoffrey Lindeman Medical Oncologist / Clinician-Scientist
Mrs Dianne Lindsay ANZ BCTG Trials Coordination Department
Dr Janine Lombard Medical Oncologist
Prof Bruce Mann Surgical Oncologist
Assoc Prof Kelly-Anne Phillips Medical Oncologist
Prof Linda Reaby AM ANZ BCTG Consumer Advisory Panel
Prof R John Simes Medical Oncologist / Statistician
Assoc Prof Raymond Snyder Medical Oncologist
Assoc Prof Martin Stockler Medical Oncologist
Dr Anne Sullivan Medical Oncologist
Prof Rob Sutherland Pathologist
Dr Craig Underhill Medical Oncologist
Dr Nicholas Wilcken Medical Oncologist
Independent Data Safety and Monitoring Committee
Prof Gordon Clunie
Chair
Dr Colin Furnival
Assoc Prof Matthew Law
Prof Martin Tattersall
Prof John Zalcberg
Consumer Advisory Panel Members
(31 March 2009)
Professor Linda Reaby AM Chair (on leave from November 2008)
ACT
Cheryl Grant
Acting Chair (November 2008 – March 2009)
NSW
Leonie Young
Acting Chair (March 2009)
Consumer Coordinator, IMPACT Program
QLD
Jennifer Bryce
VIC
Sheryl Fewster
WA
Sue Guthrie NZ
Carol Whiteside
NSW
Staff Member Listing
(for period 1 April 2008 to 31 March 2009)
Heath Badger Treatment Trials Team Leader
Lauren Boyes
Treatment Trials Team Leader
Dr James Bull
Clinical Fellow
Julie Callaghan
BCIA General Manager
Wendy Carmichael
Chief Operating Officer
Tamar Carpenter
BCIA Donor Relations Officer
Joanne Cranch
BCIA Fundraising and Finance Officer
Brooke Cross
BCIA Special Projects Officer
Haley Crotty
Trial Coordinator
Annette Dempsey
Trial Coordinator
Donna Douglass
Clinical Trials Assistant
Akiko Kato-Fong
Senior Trials Coordinator
59
Sharyn Frank
Information Support Officer
Helen Garner
Personal Assistant to Professor John Forbes
Kellie Gasson
Administrative Officer
Emma Goddard
Trial Coordinator
Rosemary Goodenough
Trial Coordinator
Leigh Hainsworth
BCIA Special Projects Officer
Belinda Hansen
Melanie Harrison
Sarah Heelis
BCIA Gift Processing Officer
Linda Hunter
Recruitment and Promotions Officer
Juliette Jameson
Administration Assistant
Judy Jobling
Trial Coordinator
Angela Johns
Trial Coordinator
Ingrid Laycock
Trial Coordinator
Jenny Leggett
BCIA Public Relations Manager
Dianne Lindsay
Head of Trials Management
Lauren Macnab
Kelly Martin
BCIA Donor Development Manager
Carlie Mavin
Trial Coordinator
Anthony Morrison
Trial Coordinator
Alison Newton
Trial Coordinator
Rose Nguyen
Trial Coordinator
Katie Oleksyn
Trial Coordinator
Lisa Paksec
Ethics and Regulatory Affairs Officer
Flonda Probert
Rebecca Ramm
Quality Assurance Officer
Hollie Ritchie
Trial Coordinator
Kristy Schmidt
Benno Schmidhauser
Trial Coordinator
Margaret Seccombe
Recruitment Coordinator
Christine Spiteri
Business Administrator – Accounts Receivable
Rochelle Thornton
Prevention Trials Team Leader
Jaclyn Wallace
Nicole Walsh
Administration Officer
Angie Ward
Trial Coordinator
Robyn Watkins
Business Administrator – Human Resources
Coralie Watson
Trial Coordinator
Julianne Webb
Trial Coordinator
Stacey Wilks
Business Administrator – Accounts Payable
Toni Worgan
Business Administrator – Human Resources
Contact Information
Trials Coordination Department
Australian New Zealand Breast Cancer Trials Group
Department of Surgical Oncology
Calvary Mater Newcastle
Locked Bag 7
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
Australian 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 protected]
Web:
www.anzbctg.org
Fundraising and Education Department
PO Box 283
The Junction NSW 2291
Australia
Phone: +61 2 4925 3022
Fax:
+61 2 4925 3068
[email protected]
Web:
www.bcia.org.au
61
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)
US
Clinical Trial Service Unit (CTSU)
UK
Cancer Research UK (CRUK)
UK
Switzerland and US
National Institute of Canada, Clinical Trials Group (NCIC-CTG)
Canada
National Surgical Adjuvant Breast and Bowel Project (NSABP)
US
Swiss Group for Clinical Cancer Research (SAKK)
Switzerland
Southwest Oncology Group (SWOG)
US
Participating Institutions
Australian Capital Territory
The Canberra Hospital Capital city – Garran ACT
New South Wales
Armidale Hospital
Regional – Armidale
Bankstown – Lidcombe Hospital
Capital city – Sydney – Bankstown
The Breast Centre
Regional – Gateshead
City – Newcastle
Coffs Harbour Health Campus
Regional – Coffs Harbour
Concord Repatriation and 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
The Mater Hospital
Capital city – Sydney – North Sydney
Nepean Cancer Care Centre
Capital city – Sydney – Kingswood
Port Macquarie Base Hospital
Regional – Port Macquarie
Prince of Wales Hospital
Capital city – Sydney – Randwick
Riverina Cancer Care Centre
Regional – Wagga Wagga
63
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
Southern Highlands Cancer Centre
Regional – Bowral
St George Hospital
Capital city – Sydney – Kogarah
St Vincent’s Hospital
Capital city – Sydney – Darlinghurst
Sydney Adventist Hospital
Capital city – Sydney – Wahroonga
Sydney Haematology and Oncology Clinic
Capital city – Sydney – Hornsby
Tamworth Rural Referral Hospital
Regional – Tamworth
The Tweed Hospital
Regional – Tweed Heads
Westmead Hospital
Capital city – Sydney – Westmead
Queensland
Mater Adult Hospital
Capital city – Brisbane – South Brisbane
Mater Private Medical Centre
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 Base Hospital
Regional – Toowoomba
Townsville General Hospital
Regional – Townsville
Wesley Medical Centre
Capital city – Brisbane – Auchenflower
South Australia
Ashford Cancer Centre
Capital city – Adelaide – Ashford
Flinders Medical Centre
Capital city – Adelaide – Bedford
The Queen Elizabeth Hospital
Capital city – Adelaide – Woodville
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
Royal Hobart Hospital
Capital city – Hobart
Victoria
The Alfred Hospital
Capital city – Melbourne – Prahran
Austin Health
Capital city – Melbourne – Heidelberg
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
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
Mercy Private Hospital Breast Unit
Capital city – Melbourne – East Melbourne
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
Fremantle Hospital
Regional – Fremantle
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
65
Group Members
Breast Physicians
Brennan, Meagan
Westmead Hospital
Chen, Juliana
NSW Breast Cancer Institute
Fox, Jane
Freese, Sonja
Gilbert, Linda
Godbolt, Patricia
Humeniuk, Vlad
Logan, David
Newcastle Private Hospital Medical Suites
Mann, Lynne
Auburn Hospital
Masters, Richard
Box Hill Hospital
Read, Katrina
Sardelic, Frank
Breastscreen North-West
Snook, Kylie
North Shore Medical Centre
Spellman, Louise
Waikato Hospital
Stoney, David
Private Practice
Westmead
NSW
Westmead
NSW
East Bentleigh
VIC
Takapuna Auckland NEW ZEALAND
Hamilton
NEW ZEALAND
Taringa
QLD
Henley Beach
SA
New Lambton HeightsNSW
Auburn
NSW
Box Hill
VIC
Melbourne
VIC
Tamworth
NSW
St Leonards
NSW
Hamilton
NEW ZEALAND
Ringwood
VIC
Study Coordinators / Research Nurses
Anderson, Robyn
Badger, Heath
ANZ BCTG
Barry, Helen
Bowers, Jayne
Wellington Blood and Cancer Centre
Boyes, Lauren
ANZ BCTG
Bracken, Karen
NHMRC Clinical Trials Centre
Bradbury, Jo
Alfred Hospital
Brown, Anna
Buchanan, Daisy
Cakir, Burcu
Cavanagh, Shelley
Waikato Hospital
Chamen, Margaret
Tamworth Hospital
Charlton, Julie
Lingard Private Hospital
Clark, Sharon
The Tweed Hospital
Cocks, Christine
Nambour General Hospital
Coulter, Kristine
Cox, Lynette
Crotty, Haley
ANZ BCTG
Dafo, Melissa
Dalley, Dale
Daly, Michelle
North Coast Cancer Institute
Dash, Denise
Mater Hospital
D’Aulerio, Giuliana
Cancer Council Clinical Trials
Dean, Sally
Dempsey, Annette
ANZ BCTG
Dhillon, Haryana
University of Sydney
Dryden, Julie
Box Hill Hospital
Dwyer, Miriam
Haematology and Oncology Clinics Of Australasia
Edhouse, Pam
Ellis, Lisa
Southern Highlands Cancer Centre
Ficatas, Helen
Box Hill Hospital
Fong, Akiko
ANZ BCTG
French, Julie
The Garvan Institute
Giddins, Suzanne
Box Hill Hospital
Goikhman, Albert
Peninsula Oncology Centre
Goodenough, Rosemary ANZ BCTG
Nedlands
Newcastle
Bunbury
Wellington South
Newcastle
Camperdown
Melbourne
Takapuna Auckland
Randwick
Camperdown
Hamilton
Tamworth
Merewether
Tweed Heads
Nambour
Wagga Wagga
Nedlands
Newcastle
Waratah
Darlinghurst
Coffs Harbour
North Sydney
Nedlands
Waratah
Newcastle
Sydney
Box Hill
Milton
St Leonards
Bowral
Box Hill
Newcastle
Darlinghurst
Box Hill
Frankston
Newcastle
WA
NSW
WA
NEW ZEALAND
NSW
NSW
VIC
NEW ZEALAND
NSW
NSW
NEW ZEALAND
NSW
NSW
NSW
QLD
NSW
WA
NSW
NSW
NSW
NSW
NSW
WA
NSW
NSW
NSW
VIC
QLD
NSW
NSW
VIC
NSW
NSW
VIC
VIC
NSW
Grundy, Renae
Hague, Wendy
Hammer, Elizabeth
Hansen, Belinda
Harrower, Yvonne
Healey, Danielle
Hemmings, Rebecca
Henderson, Kelly
Hoogeveen, Gillian
Hoque, Mafizul
Houghton, Susan
Howarth, Gabrielle
Howell, Deb
Humm, Gillian
Hurford, Melanie
Innes-Rowe, Judy
Janik, Marie
Jobling, Judith
Johns, Angela
Jolly, Lynne
Jones, Jeremy
Joppa, Barbara
Kelly, Kris
Kendall, Wendy
Kilmurray, Janice
Ko, Sarah
Laycock, Ingrid
Lim, Yen Peng
Lindsay, Dianne
Long, Sarah
Low, Jaclyn
Macnab, Lauren
Maliepaard, Sharon
Mavin, Carlie
May, Jennifer
McColl, Sonya
McCourt, Junie
Metcalfe, Debbie
Morrison, Anthony
Mueller, Helen
Murray, Bronwyn
Neave, Lorraine
Newton, Alison
Nguyen, Rose
Oleksyn, Katie
Oliver, Lesley
Paksec, Lisa
Pasanen, Leeanne
Petersen, Jennifer
Plenge, Patricia
Pollard, Elizabeth
Porten, Lauren
Power, Ann-Marie
Preston, Cecelia
Probert, Flonda
Rajandran, Hema
Ramm, Rebecca
Ranieri, Nadia
Raschke, Nicole
ANZ BCTG
Mercy Private Hospital
Tamworth Hospital
Waikato Hospital
Royal Melbourne Hospital
Bankstown-Lidcombe Hospital
Alfred Hospital
Cancer Council Victoria
Midcentral District Health
Launceston Hospital
Sydney Breast Cancer Institute
ANZ BCTG
ANZ BCTG
Auckland Hospital
The Breast Centre
Trans Radiation Oncology Group
Auckland Hospital
ANZ BCTG
Sydney Breast Cancer Institute
ANZ BCTG
King Edward Memorial Hospital
ANZ BCTG
ANZ BCTG
Frankston Hospital
ANZ BCTG
Canberra Hospital
Wesley Research Institute
Waikato Hospital
ANZ BCTG
ANZ BCTG
ANZ BCTG
ANZ BCTG
ANZ BCTG
Cancer Council Victoria
ANZ BCTG
ANZ BCTG
Hobart
Camperdown
Hobart
Newcastle
Waratah
East Melbourne
Tamworth
Hamilton
Parkville
Bankstown
Melbourne
Nedlands
Carlton
Palmerston North
Launceston
Nedlands
Camperdown
Newcastle
Newcastle
Darlinghurst
Penrith
Auckland
Gateshead
Wagga Wagga
Newcastle
Auckland
Newcastle
Camperdown
Newcastle
Subiaco
Newcastle
Newcastle
Frankston
Newcastle
Woden
Auchenflower
Penrith
Hamilton
Newcastle
Camperdown
Camperdown
Takapuna Auckland
Newcastle
Newcastle
Newcastle
Hobart
Newcastle
Fitzroy
Carlton
Darlinghurst
Nedlands
Takapuna Auckland
Fitzroy
Nambour
Newcastle
Nedlands
Newcastle
Fitzroy
Port Macquarie
TAS
NSW
TAS
NSW
NSW
VIC
NSW
NEW ZEALAND
VIC
NSW
VIC
WA
VIC
NEW ZEALAND
TAS
WA
NSW
NSW
NSW
NSW
NSW
NEW ZEALAND
NSW
NSW
NSW
NEW ZEALAND
NSW
NSW
NSW
WA
NSW
NSW
VIC
NSW
ACT
QLD
NSW
NEW ZEALAND
NSW
NSW
NSW
NEW ZEALAND
NSW
NSW
NSW
TAS
NSW
VIC
VIC
NSW
WA
NEW ZEALAND
VIC
QLD
NSW
WA
NSW
VIC
NSW
67
Raymond, Bronwyn
Richards, Kate
Rine, Cheryl
NCCI Port Macquarie Base Hospital
Ritchie, Hollie
ANZ BCTG
Roberts, Pamela
Armidale Hospital
Scarlet, Jenni
Waikato Hospital
Scher, Barbara
Cabrini Hospital
Schmidt, Kristy
ANZ BCTG
Scott, Karen
Alfred Hospital
Shaw, Susan
University of Tasmania
Sheather, Kimberley
Mater Hospital
Sherman, Peter
Silcock, Judith
The Breast Centre
Smith, Robin
Alfred Hospital
Smith, Joanne
Sporle, Jennifer
Sproule, Victoria
Stoneley, Adam
Suffolk, Jennifer
Teriana, Nory
Thomas, Wendy
Waikato Hospital
Thompson, Kerin
Auckland Regional Cancer and Blood Services
Thornton, Rochelle
ANZ BCTG
Tipene, Marita
Trend, Stephanie
Wang, Xiaolu
Liverpool Hospital
Ward, Angie
ANZ BCTG
Watson, Coralie
ANZ BCTG
Webb, Julianne
ANZ BCTG
Wegener, Vicky
Sydney West Cancer Trials Centre
Wellington, Karen
Bendigo Hospital
Whatman, Anne
Campbelltown Hospital
Whitney, Suzanne
Wilkinson, Lisa
Western Hospital
Wilks, Anne
North West Regional Hospital
Williams, Philippa
NCCI Port Macquarie Base Hospital
Winter, Rosemary
Withers, Emma
St Vincents Hospital, Melbourne
Wong, Shuet Oi
Wood, Janice
Woolett, Anne
Geelong Hospital
Wysman, Kirrilli
St Leonards
East Melbourne
Port Macquarie
Newcastle
Armidale
Hamilton
Malvern
Newcastle
Melbourne
Launceston
North Sydney
Parkville
Gateshead
Melbourne
Coffs Harbour
Fitzroy
Newcastle
Woolloongabba
Woolloongabba
Camperdown
Hamilton
Auckland
Newcastle
Penrith
Nedlands
Liverpool
Newcastle
Newcastle
Newcastle
Westmead
Bendigo
Campbelltown
Lismore
Footscray
Burnie
Port Macquarie
Westmead
Fitzroy
Bankstown
Takapuna Auckland
Geelong
Fitzroy
NSW
VIC
NSW
NSW
NSW
NEW ZEALAND
VIC
NSW
VIC
TAS
NSW
VIC
NSW
VIC
NSW
VIC
NSW
QLD
QLD
NSW
NEW ZEALAND
NEW ZEALAND
NSW
NSW
WA
NSW
NSW
NSW
NSW
NSW
VIC
NSW
NSW
VIC
TAS
NSW
NSW
VIC
NSW
NEW ZEALAND
VIC
VIC
Tweed Heads
Waratah
Brisbane
Waratah
Elizabeth Vale
Campbelltown
Palmerston North
Gosford
Bankstown
Auckland
North Sydney
Parkville
Perth
Auchenflower
NSW
NSW
QLD
NSW
SA
NSW
NEW ZEALAND
NSW
NSW
NEW ZEALAND
NSW
VIC
WA
QLD
Medical Oncologists
Abdi, Ehtesham
Abell, Fiona
Abraham, Rick
Ackland, Stephen
Adams, Jacqui
Adams, Diana
Allen, Simon
Aroney, Rodney
Asghari, Ray
Ashley, Amanda
Baron-Hay, Sally
Basser, Russell
Bayliss, Evan
Beadle, Geoffrey
The Tweed Hospital
Brisbane Private Hospital
Lyell McEwin Hospital
Gosford Hospital
Auckland Hospital
Mater Hospital
Beale, Philip
Begbie, Stephen
Port Macquarie Base Hospital
Beith, Jane
Bell, Richard
Geelong Hospital
Bell, David
Biddulph, Jane
Blum, Robert
Bendigo Hospital
Bonaventura, Antonino
Bond, Rodney
Ballarat Oncology and Haematology Services
Boyce, Adam
Boyle, Fran
Mater Hospital
Brigham, Brian
Briscoe, Karen
Coffs Harbour Health Campus
Buck, Martin
Bunbury Hospital
Bull, James
ANZ BCTG
Burns, Ivon
Byard, Ian
Byrne, Michael
Chan, Arlene
Mount Hospital
Chantrill, Lorraine
Cheong, Kerry Alison
Chern, Boris
Redcliffe Hospital
Chipman, Mitchell
Warringal Medical Centre
Chirgwin, Jacquie
Box Hill / Maroondah Hospital
Clarke, Kerrie
Coates, Alan
International Breast Cancer Study Group
Colosimo, Maree
Holy Spirit Northside Hospital
Craft, Paul
Canberra Hospital
Cronk, Michelle
Dalley, David
Davis, Alison
The Canberra Hospital
Day, Fiona
De Boer, Richard
Royal Melbourne Hospital / Western Hospital
De Souza, Paul
St George Hospital
Della-Fiorentina, Stephen Campbelltown Hospital
Dewar, Joanna
Durrant, Simon
Dzhelali, Marina
Edwards, James
Eek, Richard
Liverpool Hospital
Findlay, Michael
Auckland Hospital
Fitzharris, Bernie
Foo, Serene
Austin Health
Forgeson, Garry
Forouzesh, Bahram
Francis, Prue
Friedlander, Michael
Gainford, Corona
Ganju, Vinod
Frankston Hospital
Goggin, Leigh
Goldrick, Amanda
Liverpool Hospital
Goldstein, David
Goss, Geraldine
Maroondah Hospital Breast Clinic
Green, Michael
Royal Melbourne Hospital / Western Hospital
Grimison, Peter
Grossi, Marisa
Grygiel, John
Hamilton, Kate
Ballarat Health Services
Hamilton, Anne
Camperdown
Port Macquarie
Camperdown
Geelong
St Leonards
Auckland
Bendigo
Waratah
Wendouree
Lismore
North Sydney
Randwick
Coffs Harbour
Bunbury
Newcastle
Fitzroy
West Hobart
Gidgegannup
Perth
Campbelltown
Ashford
Redcliffe
Heidelberg
Box Hill
Wodonga
Centennial Park
Chermside
Woden
Nambour
Darlinghurst
Garran
East Melbourne
Parkville
Kogarah
Campbelltown
Nedlands
Herston
Wellington South
Wellington South
Liverpool
Auckland
Christchurch
Heidelberg
Palmerston North
Wagga Wagga
East Melbourne
Randwick
Camperdown
Frankston
Nedlands
Liverpool
Randwick
Ringwood East
Parkville
Camperdown
East Melbourne
Darlinghurst
Ballarat
Camperdown
NSW
NSW
NSW
VIC
NSW
NEW ZEALAND
VIC
NSW
VIC
NSW
NSW
NSW
NSW
WA
NSW
VIC
TAS
WA
WA
NSW
SA
QLD
VIC
VIC
VIC
NSW
QLD
ACT
QLD
NSW
ACT
VIC
VIC
NSW
NSW
WA
QLD
NEW ZEALAND
NEW ZEALAND
NSW
NEW ZEALAND
NEW ZEALAND
VIC
NEW ZEALAND
NSW
VIC
NSW
NSW
VIC
WA
NSW
NSW
VIC
VIC
NSW
VIC
NSW
VIC
NSW
69
Harnett, Paul
Harris, Marion
Harrup, Rosemary
Harvey, Vernon
Hawson, Geoffrey
Haydon, Andrew
Hill, Jane
Hitchins, Robert
Holmes, Romayne
Hovey, Elizabeth
Isaacs, Richard
Jameson, Michael
Jeffery, Mark
Jennens, Ross
Joshi, Rohit
Joubert, Warren
Kannourakis, George
Karapetis, Christos
Kefford, Richard
Kennedy, Ian
Kichenadasse, Ganessan
Kiely, Belinda
Kirsten, Fred
Koczwara, Bogda
Kotasek, Dusan
Kuper-Hommel, Marion
Lee, Chee Khoon
Lewis, Craig
Lindeman, Geoffrey
Loi, Sherene
Lombard, Janine
Lowenthal, Ray
Lynch, Jodi
Mainwaring, Paul
Malden, Trevor
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
Ng, Siobhan
Nottage, Michelle
Nowak, Anna
Olver, Ian
Patterson, Kevin
Pavlakis, Nick
Perez, David
Phillips, Kelly-Anne
Pittman, Ken
Porter, David
Potasz, Nicole
Ransom, David
Westmead Hospital
Westmead
East Bentleigh
Hobart
Auckland Hospital
Auckland
Nambour
Alfred Hospital
Melbourne
Wagga Wagga
Pacific Private Clinic
Southport
Alfred Hospital
Melbourne
Randwick
Palmerston North
Waikato Hospital
Hamilton Christchurch Hospital
Christchurch
Mercy Private Hospital
East Melbourne
Adelaide
Woolloongabba
Ballarat Oncology and Haematology Services
Wendouree
Bedford Park
Westmead Hospital
Westmead
Waikato Hospital
Hamilton
Bedford Park
Camperdown
Bankstown
Bedford Park
Ashford
Waikato Hospital
Hamilton
Camperdown
Randwick
Parkville
Breast International Group
Waratah
Hobart
St George Hospital
Kogarah
Haematology and Oncology Clinics of Australasia Pty Ltd South Brisbane
St Andrew’s Medical Centre
Adelaide
Royal North Shore Hospital / Private
Hornsby
Herston
Auckland Hospital
Auckland
Fitzroy
Dunedin Hospital
Dunedin
Geelong Hospital
Geelong
Westmead Hospital
Westmead
East Melbourne
Nedlands
East Melbourne
Dunedin Hospital
Dunedin
Cork University Hospital
Cork
Subiaco
Herston
Nedlands
The Cancer Council Australia
Sydney
Queen Elizabeth Hospital
Woodville
Armidale Hospital
Armidale
Dunedin Hospital
Dunedin
East Melbourne
Woodville
Auckland Hospital
Auckland
Frankston Hospital
Frankston
Subiaco
NSW
VIC
TAS
NEW ZEALAND
QLD
VIC
NSW
QLD
VIC
NSW
NEW ZEALAND
NEW ZEALAND
NEW ZEALAND
VIC
SA
QLD
VIC
SA
NSW
NEW ZEALAND
SA
NSW
NSW
SA
SA
NEW ZEALAND
NSW
NSW
VIC
BRUSSELS
NSW
TAS
NSW
QLD
SA
NSW
QLD
NEW ZEALAND
VIC
NEW ZEALAND
VIC
NSW
VIC
WA
VIC
NEW ZEALAND
IRELAND
WA
QLD
WA
NSW
SA
NSW
NEW ZEALAND
VIC
SA
NEW ZEALAND
VIC
WA
Redfern, Andrew
Richardson, Gary
Robinson, Bridget
Rutovitz, Joseph
Sabesan, Sabe
Schwarz, Max
Scott, Claire
Segelov, Eva
Selva-Nayagam, Sid
Sewak, Sanjeev
Shannon, Catherine
Shannon, Jenny
Simes, John
Simpson, Andrew
Snyder, Raymond
Stewart, Josephine
Stewart, John
Stockler, Martin
Strickland, Andrew
Sullivan, Anne
Tattersall, Martin
Taylor, Anne
Thompson, Paul
Thomson, Jacquelyn
Toner, Guy
Tsoi, Daphne
Underhill, Craig
Van Hazel, Guy
Vasey, Paul
Walpole, Euan
Ward, Robyn
White, Shane
White, Michelle
Wilcken, Nicholas
Wong, Karmen
Woodward, Natasha
Wyld, David
Young, Rosemary
Perth
Cabrini Hospital
Malvern
Christchurch
Sydney Haematology and Oncology Clinics
Hornsby
Townsville Cancer Centre
Douglas
Alfred Hospital
Melbourne
Walter and Eliza Hall Institute
Parkville
Darlinghurst
Adelaide
Geelong Hospital
Geelong
South Brisbane
Penrith
Camperdown
Wellington South
Fitzroy
Austin Health
Heidelberg
Waratah
Camperdown
East Bentleigh
Camperdown
Camperdown
Adelaide
Auckland Hospital
Auckland
Frankston Hospital
Frankston
East Melbourne
Nedlands
Wodonga
Nedlands
Auchenflower
Woolloongabba
Darlinghurst
Austin Health
Heidelberg
East Bentleigh
Westmead Hospital
Westmead
Gleneagles Medical Centre
Woolloongabba
Herston
Hobart
WA
VIC
NEW ZEALAND
NSW
QLD
VIC
VIC
NSW
SA
VIC
QLD
NSW
NSW
NEW ZEALAND
VIC
VIC
NSW
NSW
VIC
NSW
NSW
SA
NEW ZEALAND
VIC
VIC
WA
VIC
WA
QLD
QLD
NSW
VIC
VIC
NSW
SINGAPORE
QLD
QLD
TAS
Non Clinical Participants
Bryce, Jennifer
Callaghan, Julie
Carmichael, Wendy
Carpenter, Tamar
Cranch, Joanne
Douglass, Donna
Fewster, Sheryl
Forbes, Jenny
Frank, Sharyn
Garner, Helen
Gasson, Kellie
Grant, Cheryl
Guthrie, Susan
Hainsworth, Leigh
Heelis, Sarah
Hunter, Linda
Jameson, Juliette
Leggett, Jennifer
ANZ BCTG
ANZ BCTG
Hunter Breast Screen
ANZ BCTG
ANZ BCTG
ANZ BCTG
ANZ BCTG
ANZ BCTG
Camberwell
Newcastle
Newcastle
Newcastle
Newcastle
Newcastle
South Perth
Newcastle
Newcastle
Newcastle
Newcastle
Denistone
Auckland
Newcastle
Newcastle
Newcastle
Newcastle
Newcastle
VIC
NSW
NSW
NSW
NSW
NSW
WA
NSW
NSW
NSW
NSW
NSW
NEW ZEALAND
NSW
NSW
NSW
NSW
NSW
71
Martin, Kelly
Preece, Debbie
Reaby, Linda
Seccombe, Margaret
Spiteri, Christine
ANZ BCTG
Walker, Melanie
Beleura Private Hospital
Walsh, Nicole
ANZ BCTG
Watkins, Robyn
ANZ BCTG
Westland, Kristie
Maroondah Hospital Breast Clinic
Whiteside, Carol
Wilks, Stacey
ANZ BCTG
Worgan, Toni
Young, Leonie
Newcastle
Cardiff Heights
Belconnen
Valentine
Newcastle
Mornington
Newcastle
Newcastle
Ringwood East
Kotara South
Newcastle
Marylands
Sunnybank
NSW
NSW
ACT
NSW
NSW
VIC
NSW
NSW
VIC
NSW
NSW
NSW
QLD
Waratah
NSW
Sydney
Herston
Sydney
Sydney
Sydney
Fitzroy
Parkville
NSW
QLD
NSW
NSW
NSW
VIC
VIC
Melbourne
East Melbourne
VIC
VIC
Westmead
NSW
Maroochydore
QLD
Collingwood
Collingwood
Takapuna Auckland
Woolloongabba
Herston
Darlinghurst
Auckland
Darlinghurst
East Bentleigh
Darlinghurst
VIC
VIC
NEW ZEALAND
QLD
QLD
NSW
NEW ZEALAND
NSW
VIC
NSW
Westmead
Hamilton
Christchurch
NSW
NEW ZEALAND
NEW ZEALAND
Nurse Counsellors
Hussain, Carole
Clinical Researchers
Butow, Phyllis
Eakin, Elizabeth
Juraskova, Ilona
King, Madeleine
Smith, Allan Benaud
Thompson, Erik
Visvader, Jane
Cancer Prevention Research Centre
Psycho-Oncology Co-Operative Research Group
University of Melbourne
Walter and Eliza Hall Institute
Endocrinologists
Davis, Susan
Stern, Cathryn
Alfred Hospital
Private Practice
Geneticists
Kirk, Judy
Westmead Hospital
Haematologists
Kellner, Sybil
Cotton Tree Specialist Centre
Pathologists
Brown, Robert
Constable, Leonie
Craik, Jan
Francis, Glenn
Lakhani, Sunil
Millar, Ewan
Miller, Mary
O’Toole, Sandra
Susil, Beatrice
Sutherland, Robert
Melbourne Pathology
Melbourne Pathology
University of Queensland
Garvan Institute of Medical Research
Auckland Hospital
Radiation Oncologists
Ahern, Verity
Angell, Ruth
Atkinson, Christopher
Westmead Hospital
Waikato Hospital
Benjamin, Chellaraj
Bishop, Michelle
Blakey, David
Borg, Martin
Bryant, Guy
Burke, Marie-Frances
Byram, David
Carroll, Susan
Chua, Boon
Delaney, Geoff
Drummond, Roslyn
Francis, Michael
Gauden, Stan
Graham, Peter
Harvey, Jennifer
Ho, Annie
Jacob, George
Jeal, Peter
Johnson, Carol
Joseph, David
Kenny, Lizbeth
Lonergan, Denise
Matthews, John
Morgan, Graeme
Peres, Helen
Phillips, Claire
Round, Glenys
Stevens, Mark
Taylor, Karen
Wynne, Christopher
Zissiadis, Yvonne
Auckland Hospital
Peter MacCallum Cancer Institute/Bendigo Hosp
Frankston Radiation
Adelaide Radiotherapy Centre
Southern Zone Radiation Oncology
Launceston Hospital
Liverpool Hospital
Geelong Hospital
WP Holman Clinic
St George Hospital
Mater Queensland Radium Institute
Sydney Adventist Hospital
Canberra Hospital
Campbelltown Hospital
Auckland Hospital
East Coast Cancer Centre
Waikato Hospital
William Buckland Radiotherapy Centre
Auckland
Bendigo
Frankston
Adelaide
South Brisbane
Auchenflower
Launceston
Camperdown
East Melbourne
Liverpool
East Melbourne
Geelong
Launceston
Kogarah
South Brisbane
Wahroonga
Woden
Wagga Wagga
Wellington South
Nedlands
Herston
Campbelltown
Auckland
St Leonards
South Brisbane
East Melbourne
Hamilton
Wagga Wagga
Melbourne
Christchurch
Perth
NEW ZEALAND
VIC
VIC
SA
QLD
QLD
TAS
NSW
VIC
NSW
VIC
VIC
TAS
NSW
QLD
NSW
ACT
NSW
NEW ZEALAND
WA
QLD
NSW
NEW ZEALAND
NSW
QLD
VIC
NEW ZEALAND
NSW
VIC
NEW ZEALAND
WA
Warana
Nambour West
Otahuhu, Auckland
Auckland
QLD
QLD
NEW ZEALAND
NEW ZEALAND
Camperdown
Newcastle
North Ryde
Camperdown
NSW
NSW
NSW
NSW
Kwazulu Natal
Camperdown
Gateshead
Hamilton
Gateshead
Hamilton
Brisbane
Strathfield
Takapuna Auckland
East Bentleigh
Perth
SOUTH AFRICA
NSW
NSW
NEW ZEALAND
NSW
NEW ZEALAND
QLD
NSW
NEW ZEALAND
VIC
WA
Radiologists
Paszkowski, Andrew
Pfeiffer, Deborah
Urry, Sally
Whitlock, Jeremy
Lakeview Imaging
Breast Screen Queensland Nambour Service
Middlemore Hospital
Auckland Hospital
Statistician/Computer Scientists
Gebski, Val
Green, Andrew
Hudson, Malcolm
Zannino, Diana
Newton Green Technologies
Macquarie University
Breast Surgeons
Cacala, Sharon
Carmalt, Hugh
Clark, David
Creighton, Jane
Douglas, Charles
Ehrstrom, Marcus
Fryar, Barry
Gluch, Laurence
Harman, Richard
Hart, Stewart
Ingram, David
Greys Hospital
The Breast Centre
Waikato Hospital
The Breast Centre
Waikato Hospital
Private Practice
The Strathfield Breast Centre
Mount Hospital
73
Juhasz, Eva
Krishnan, Sandra
Lambley, Jason
Mater Medical Centre
Laura, Sharon
Private Practice
Law, Michael
Mitcham Private Consulting Suites
Littlejohn, David
Private Practice
Mak, Cindy
Concord Hospital
Moore, Katrina
O’Brien, Jane
O’Donoghue, Gerrard
Pitcher, Meron
Western Hospital
Sacks, Nigel
Lyell McEwin Hospital
Scott, Belinda
Breast Associates
Speakman, David
Tasevski, Robert
Thomson, David
Walsh, David
Whineray Kelly, Erica
Takapuna Auckland
Westmead
Cleveland
East Gosford
Mitcham
Wagga Wagga
Concord
St Leonards
East Melbourne
Parkville
Footscray
Elizabeth Vale
Auckland
East Melbourne
Parkville
Randwick
Woodville
Castor Bay
NEW ZEALAND
NSW
QLD
NSW
VIC
NSW
NSW
NSW
VIC
VIC
VIC
SA
NEW ZEALAND
VIC
VIC
NSW
SA
NEW ZEALAND
Parkville
VIC
Torquay
UNITED KINGDOM
Adelaide
SA
Takapuna Auckland
Nambour
Cabramatta
Westmead
Waratah
Camden
Coffs Harbour
Bankstown
Campbelltown
NEW ZEALAND
QLD
NSW
NSW
NSW
NSW
NSW
NSW
NSW
Heidelberg
Woolloongabba
Melrose Park
Bankstown
Hamilton
Heidelberg
Bendigo
Parkville
Nambour
Lismore
Nambour
Nambour
Parkville
Westmead
VIC
QLD
SA
NSW
NEW ZEALAND
VIC
VIC
VIC
QLD
NSW
QLD
QLD
VIC
NSW
Clinical Fellow / Surgeon
Skandarajah, Anita
Consultant Surgeon
Donnelly, Peter
Torbay Hospital
Endocrine Surgeon
Malycha, Peter
General Surgeons
Gerred, Susan
Grieve, David
Lee, Richard
Leong, Su-Lin
Levy, Richard
Lim, Edwin
Ross, William
Soon, Patsy
Stewart, Katherine
Medical Centre
Melanoma Unit
Private Practice
Coffs Harbour Surgical Group
Private Practice
Surgical Oncologists
Baker, Caroline
Bennett, Ian
Birrell, Stephen
Bonar, Francis John (Tom)
Campbell, Ian
Castles, Lindsay
Chambers, Kevin
Collins, John
Creighton, Lisa
Curtin, Austin
Darcy, Justin
Donovan, Michael
Efe, Narine
Elder, Elisabeth
Austin Repatriation Medical Centre
Jill Need Breast Cancer Trials Centre
Waikato Hospital
Austin Repatriation Medical Centre
Bendigo Hospital
Forbes, John
Waratah
Foster, Hamish
Lismore
French, James
Westmead Hospital
Westmead
Furnival, Colin
Auchenflower
Gale, Timothy
Alfred Hosp, Box Hill Hosp, Monash Med Centre
Melbourne
Gill, Peter
Adelaide
Gillett, David
The Strathfield Breast Centre
Strathfield
Gregory, Peter
Private Practice
Brighton
Hargreaves, Warren
Darlinghurst
Hastrich, Diana
Mount Hospital
Perth
Henderson, Michael
East Melbourne
Hughes, Malcolm
Private Practice
Castle Hill
Hughes, Thomas
San Clinic
Wahroonga
Hyams, David
Aptium Oncology Inc.
Jones, Wayne
Auckland Hospital
Auckland
Kay, Ron
Auckland
Kitchen, Paul
Fitzroy
Kling, Neill
Bunbury
Mann, Bruce
Parkville
Millar, Robert
Parkville
Miller, Iain
Private Practice
Sale
Miller, Julie
Parkville
Mitchell, Gregory
Geelong Hospital
Geelong
Molland, Gail
Castle Hill Day Surgery
Castle Hill
Moon, Dominic
Westmead Hospital
Westmead
Murphy, Craig
Royal Melbourne Hospital / Private
Parkville
Neil, Suzanne
East Bentleigh
Ng, Alexander
Auckland
Noushi, Farnoush
NSW Cancer Institute
Lindfield
Oliver, David
Murdoch
Pyke, Christopher
South Brisbane
Rice, Mark
Dubbo Base Hospital
Dubbo
Robertson, Robert
Private Practice
Christchurch
Saunders, Christobel
University of Western Australia
Perth
Serpell, Jonathan
Frankston Oncology Group
Frankston
Shah, Aashit
Liverpool Hospital
Liverpool
Simon, Robert
Lismore
Spillane, Andrew
North Sydney
Sywak, Mark
St Leonards
Townend, David
Lismore
Ung, Owen
Westmead Hospital
Westmead
Wetzig, Neil
Auchenflower
Wilkinson, Stephen
Hobart Private Hospital
Hobart
NSW
NSW
NSW
QLD
VIC
SA
NSW
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
75
Funders and Supporters
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
Mary Kay
The Toner Recycler
Dateline Imports
Lowe
2008 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
Volunteers
2008 Avon Race for Research Volunteers
Mr Bob Adams
Ms Jenny Dunne
Mrs Margaret McNaughton
Ms Kim Bauer
Mrs Cate Dymond
Mrs Simone Montgomery
Ms Jennifer Beldham
Mr Matthew Ferrie
Mr Josh Mowbray
Mrs Pam Bennett
Mrs Jenny Forbes
Mr Geoff Muldoon
Mr Rob Bennett
Ms Lyn Freeman
Mr Matthew Nolan
Ms Susan Bennett
Mr Andy Gertchin
Mr Chris Nottle
Mr William Bennett
Ms Teegan Goolmer
Mr Steve Petrassie
Ms Joanne Buckingham
Mr Andrew Green
Ms Debbie Preece
Mr Kevin Burbridge
Mr Paul Hawker
Mr Chris Regent
Ms Hannah Connor
Mrs Gabrielle Hussain
Mrs Gailene Rowe
Mr Jim Cowburn
Ms Bridie Ingham
Mr John Scanlon
Mr Paul Cranch
Mrs Cathy Ingham
Mrs Lyn Scanlon
Ms Giselle Crawford
Mr James Ingham
Ms Becky Stokes
Mr Peter Dall
Mr Neil Ingham
Mr Graham Walker
Mr Derek Davelaar
Ms Marian Jones
Mrs Cathy Walmsley
Mrs Carolyn Davies
Mr Chris Leggett
Ms Maria Walz
Mr Trevor Davies
Mr Paul Lindsay
Ms Fiona Way
Ms Marea Davoren
Mr Andrew Martin
Mrs Dianne West
Mr John Donn
Mr Anthony Martin
Ms Jessica White
Mrs Marilyn Donn
Mrs Judith Mason
Mr Gordon Whitehead
* ANZ BCTG and BCIA staff were also volunteers at this event.
77
Financial Report
The ANZ BCTG 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 ANZ BCTG is governed by a Board of Directors and its purpose is outlined in the Group’s
Constitution. The Board of Directors established a Finance and Audit sub-Committee (FAC) to assist
with its financial oversight responsibilities. This Board sub-Committee has a Terms of Reference and
meets four times per year.
Financial management of the ANZ BCTG has two main facets:
■■
management of ANZ BCTG finances and resources;
■■
management of competitive and other grant funds administered by other Institutions.
Financial Management
Because of its company status, the majority of the Group’s income is managed directly by the Group.
The Chief Operating Officer undertakes day to day financial management of the Group according to
the delegations vested in this position by the Board, and ensures the ANZ BCTG adheres to applicable
Australian corporate, taxation and charity legislation.
Sources of ANZ BCTG income:
■■
clinical trials income (pharmaceutical partnerships, international collaborative group partnerships,
untied education grants);
■■
competitive grants awarded to the ANZ BCTG (Cancer Australia);
■■
fundraising income (donations, special events, corporate sponsorships, bequests);
■■
other income (ASM registrations and sponsorships, sundry).
Areas of ANZ BCTG expenditure:
■■
clinical trials randomisation and statistical services;
■■
clinical trials central activation, coordination and monitoring activities;
■■
clinical trials data management reimbursement payments to participating institutions;
■■
ANZ BCTG Annual Scientific Meeting;
■■
fundraising expenses;
■■
staff member salaries;
■■
other recurrent monthly infrastructure costs and core business expenses.
Financial Management of Competitive Grant Funds Administered by other Institutions
The ANZ BCTG 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:
■■
National Health and Medical Research Council (NHMRC) (government);
■■
Cancer Institute NSW (government);
■■
Cancer Councils (government/private);
■■
National Breast Cancer Foundation (private);
■■
Other Trusts and Foundations.
79
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 ANZ BCTG’s usual administering institution and
competitive grant funding administered by this or other institutions is not shown in the financial
statements of the ANZ BCTG.
During the reporting period the ANZ BCTG held the following competitive grants administered by other
institutions:
■■
Six NHMRC project grants supporting the following trials: IBIS-I, IBIS-II, LATER, SOFT and TEXT,
Co-SOFT and ANZ 0502;
■■
One Cancer Institute NSW infrastructure grant.
The Group’s competitive grant holdings amounted to just over $2 million for the reporting period.
Financial Statements
The statements contained in this Financial Report are a summary of the audited accounts for the
financial year ended 31 March 2009. Full audited financial statements are available by contacting the
ANZ BCTG.
Any ANZ BCTG surplus is committed to supporting current and future ANZ BCTG research projects.
All ANZ BCTG payroll liabilities are annually expensed to the external suppliers which manage the
ANZ BCTG’s payroll.
Income Statement
2009
$
2008
$
Revenues from ordinary activities
9,346,985
7,430,175
Clinical trials protocol and per patient expenses
1,799,161
1,557,214
Clinical trials program expenses
2,427,042
1,583,643
Donations and fundraising expenses
1,266,276
1,073,005
Scientific, committee and administrative meetings expenses
544,239
491,036
Other expenses
601,983
414,686
6,638,701
5,119,584
Net surplus from ordinary activities
2,708,284
2,310,601
Total changes in equity
2,708,284
2,310,601
Balance Sheet
2009
$
2008
$
Cash assets
11,353,150
9,366,530
Receivables
2,017,814
1,051,052
240,700
333,146
13,611,664
10,750,728
Other financial assets
113,166
64,203
Property, plant and equipment
462,768
129,285
Total non-current assets
575,934
193,488
14,187,598
10,944,216
Payables
2,544,837
2,009,739
Total current liabilities
2,544,837
2,009,739
TOTAL LIABILITIES
2,544,837
2,009,739
11,642,761
8,934,477
Accumulated funds
11,642,761
8,934,477
TOTAL ACCUMULATED FUNDS
11,642,761
8,934,477
CURRENT ASSETS
Other financial assets
Total current assets
NON-CURRENT ASSETS
TOTAL ASSETS
CURRENT LIABILITIES
NET ASSETS
ACCUMULATED FUNDS
81
Summary Income and Expenditure Statement
2009
$
2008
$
Clinical trials income
3,049,834
1,649,683
Donations and fundraising income
4,856,949
4,379,037
Annual Scientific Meeting income
287,543
195,532
Cancer Australia infrastructure grant
342,090
511,705
55,000
1,000
Bank interest
565,093
477,546
Other income
190,476
215,682
9,346,985
7,430,185
Clinical trials protocol and per patient expenses
1,799,161
1,557,214
Clinical trials program expenses
2,427,042
1,583,643
Donations and fundraising expenses
1,266,276
1,073,005
Scientific, committee and administrative meetings expenses
544,239
491,036
Other expenses
601,983
414,686
TOTAL EXPENSES
6,638,701
5,119,584
NET SURPLUS
2,708,284
2,310,601
INCOME
Bequests
TOTAL INCOME
EXPENDITURE
Income
Clinical trials
Donations and fundraising
Bequests
Cancer Australia infrastructure grant
Bank interest
Other
Expenditure
Clinical trials
Donations and fundraising
Scientific, committee and
administrative meetings
Other
83
Cashflow Statement
CASH FLOWS FROM OPERATING ACTIVITIES
2009
$
Inflow/
(Outflow)
2008
$
Inflow/
(Outflow)
Receipts from customers, donors and external funding
8,128,497
7,430,751
565,093
477,546
(6,253,714)
(5,083,980)
2,439,876
2,824,317
Purchase of property, plant and equipment
(453,256)
(62,700)
Net cash by (used in) investing activities
(453,256)
(62,700)
Net increase/(decrease) in cash held
1,986,620
2,761,617
Cash at the beginning of the year
9,366,530
6,604,913
11,353,150
9,366,530
2009
$
2008
$
2,844,488
2,680,075
797,452
726,602
2,047,036
1,953,473
Income
566,534
544,887
Expense
34,044
24,246
532,490
520,641
1,445,927
1,154,075
434,780
322,157
Net income
1,011,147
831,918
TOTAL INCOME
4,856,949
4,379,037
TOTAL EXPENDITURE
1,266,276
1,073,005
NET INCOME FROM FUNDRAISING
3,590,673
3,306,032
Interest received
Payments to suppliers and employees
Net cash provided by (used in) operating activities
CASH FLOWS FROM INVESTING ACTIVITIES
Cash at the end of the year
BCIA Fundraising Income and Expenditure Statement
DONATIONS
Income
Expense
Net income
CORPORATE SUPPORT
Net income
SPECIAL EVENTS AND PROJECTS
Income
Expense
Publications
01/01/2008 to 31/12/2008
696.
ATAC Trialists’ Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage
breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol 2008; 9:45-53.
697.
Bernhard J, Zahrieh D, Zhang JJ, Martinelli G, Basser R, Hürny C, Forbes JF, Aebi S, Yeo W,
Thürlimann B, Green MD, Colleoni M, Gelber RD, Castiglione-Gertsch M, Price KN, Goldhirsch A,
Coates AS, for the International Breast Cancer Study Group (IBCSG). Quality of life and qualityadjusted survival (Q-TWiST) in patients receiving dose-intensive or standard dose chemotherapy
for high-risk primary breast cancer. Br J Cancer 2008; 98:25-33.
698.
Crivellari D, Sun Z, Coates AS, Price KN, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF,
Paridaens R, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Gladieff L,
Rabaglio M, Smith I, Chirgwin J, Goldhirsch A. Letrozole compared with tamoxifen for elderly
patients with endocrine-responsive early breast cancer in the BIG 1-98 trial: efficacy, treatment
and adverse events. J Clin Oncol 2008; 26(12):1972-1979.
699.
Crown JP, Burris III HA, Boyle F, Jones S, Koehler M, Newstat BO, Parikh R, Oliva C, Preston A,
Byrne J, Chan S. Pooled analysis of diarrhea events in patients with cancer treated with lapatinib.
Breast Cancer Res Treat 2008; 112:317-325.
700.
Cuzick J, Sestak I, Cella D, Fallowfield L, on behalf of the ATAC Trialists’ Group. Treatmentemergent endocrine symptoms and the risk of breast cancer recurrence: a retrospective analysis
of the ATAC trial. Lancet Oncol 2008; 9(12):1143-1148.
701.
Dang CT, Lin NU, Lake D, Dickler MN, Modi S, Seidman AD, Steingart RM, Norton L, Winer EP,
Hudis CA. Preliminary safety results of dose-dense (dd) doxorubicin and cyclophosphamide (AC)
followed by weekly paclitaxel (P) with trastuzumab (T) and lapatinib (L) in HER2 overexpressed/
amplified breast cancer (BCA). ASCO 2008; 518.
702.
de Azambuja E, McCaskill-Stevens W, Quinaux E, Buyse M, Crown J, Francis P, Gelber R, PiccartGebhart M. The effect of body mass index (BMI) on disease-free and overall survival in nodepositive breast cancer treated with docetaxel and doxorubicin-containing adjuvant chemotherapy:
the experience of the BIG 02-98 trial. European Breast Cancer Conference 2008; Abstract 29.
703.
Del Mastro L. The difficult decision-making process for using or not using adjuvant chemotherapy
in premenopausal endocrine-responsive breast cancer patients. Ann Oncol 2008; 19:1213-1215.
704.
Dowsett M, Allred C, Knox J, Quinn E, Salter J, Wale C, Cuzick J, Houghton J, Williams N, Mallon
E, Bishop H, Ellis I, Larsimont D, Sasano H, Carder P, Cussac AL, Knox F, Speirs V, Forbes J,
Buzdar A. Relationship between quantitative estrogen and progesterone receptor expression and
human epidermal growth factor receptor 2 (HER-2) status with recurrence in arimidex, tamoxifen,
alone or in combination trial. J Clin Oncol 2008; 26(7):1059-1065.
705.
Eastell R, Adamas JE, Coleman RE, Howell A, Hannon RA, Cuzick J, Mackey JR, Beckmann
MW, Clack G. Effect of anastrozole on bone mineral density: 5-year results from the anastrozole,
tamoxifen, alone or in combination trial 18233230. J Clin Oncol 2008; 26(7):1051-1058.
85
706.
Fleming GF and Francis P. Commentary on: Survival after adjuvant oophorectomy and tamoxifen
in operable breast cancer in premenopausal women. Breast Diseases: A Year Book Quarterly
2008; 19:278-279.
707.
Francis P, Crown J, Di Leo A, Buyse M, Balil A, Andersson M, Nordenskjöld B, Lang I, Jakesz R,
Vorobiof D, Gutiérrez J, van Hazel G, Dolci S, Jamin S, Bendahmane B, Gelber RD, Goldhirsch
A, Castiglione-Gertsch M, Piccart-Gebhart M on behalf of the BIG 02-98 Collaborative Group.
Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast
International Group 02-98 randomised trial. J Natl Cancer Inst 2008; 100:121-133.
708.
Francis P. Surprised by Hope. J Clin Oncol 2008; 26(36):6001-6002.
709.
Gao J, Warren R, Warren-Forward H, Forbes JF. Reproducibility of visual assessment of
mammographic density. Breast Cancer Res Treat 2008; 180:121-127.
710.
Gianni L, Cole BF, Panzini I, Snyder R, Holmberg SB, Byrne M, Crivellari D, Colleoni M, Aebi S,
Simoncini E, Pagani O, Castiglione-Gertsch M, Price KN, Goldhirsch A, Coates AS, Ravaioli A.
Anemia during adjuvant non-taxane chemotherapy for early breast cancer: incidence and risk
factors from two trials of the International Breast Cancer Study Group. Support Care Cancer
2008; 16:67-74.
711.
Goss PE, Ingle JN, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M,
Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS,
Cameron DA, Palmer MJ, Tu D. Late extended adjuvant treatment with letrozole improves
outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. J Clin
Oncol 2008; 26(12):1948-1955.
712.
Grimison PS, Coates AS, Forbes JF, Cuzick J, Furnival C, Craft PS, Snyder RD, Thornton R,
Lindsay DF, Simes RJ. Tamoxifen for the prevention of breast cancer: importance of specific
aspects of health-related quality of life (HRQL) to global health status in the ANZ BCTG substudy
of IBIS-I (ANZ 92P1) COSA 2008; ABSZ2-VFS96-2PFJQ-CK839.
713.
Gruber G, Cole BF, Castiglione-Gertsch M, Holmberg SB, Lindtner J, Golouh R, Collins J,
Crivellari D, Thürlimann B, Simoncini E, Fey MF, Gelber RD, Coates AS, Price KN, Goldhirsch
A, Viale G, Gusterson BA, for the International Breast Cancer Study Group. Extracapsular
tumor spread and the risk of local, axillary and supraclavicular recurrence in node-positive,
premenopausal patients with breast cancer. Ann Oncol 2008; 19:1393-1401.
714.
Holmberg L, Iversen O-E, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, Jassem
J, Dobaczewska D, Fjosne HE, Peralta O, Arriagada R, Holmqvist M, Maenpa J. Increased risk
of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst
2008; 100:475-482.
715.
Ingle JN, Tu D, Pater JL, Muss HB, Martino S, Robert NJ, Piccart MJ, Castiglione M, Shepherd LE,
Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer
MJ, Goss PE. Intent-to-treat analysis of the placebo-controlled trial of letrozole for extended
adjuvant therapy in early breast cancer: NCIC CTG MA.17. Ann Oncol 2008; 19:877-882.
716.
Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes
JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast
cancer prevention trial (IBIS-II DCIS). Health Expectations 2008; 11:252-262.
717.
Leyland-Jones BR, Ambrosone CB, Bartlett J, Ellis MJC, Enos RA, Raji A, Pins MR, Zujewski JA,
Hewitt SM, Forbes JF, Abramovitz M, Braga S, Cardoso F, Harbeck N, Denkert C, Jewell SD.
Recommendations for collection and handling of specimens from Group Breast Cancer Clinical
Trials. J Clin Oncol 2008; 26(34):5638-5644.
718.
Muss HB, Tu D, Ingle JN, Martino S, Robert NJ, Pater JL, Whelan TJ, Palmer MJ, Piccart MJ,
Shepherd LE, Pritchard KI, He Z, Goss PE. Efficacy, toxicity, and quality of life in older women with
early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG
Intergroup trial MA.17. J Clin Oncol 2008; 26(12):1956-1964.
719.
Pestalozzi B, Zahrieh D, Mallon E, Gusterson BA, Price KN, Gelber RD, Holmberg SB, Lindtner
J, Snyder R, Thürlimann B, Murray E, Viale G, Castiglione-Gertsch M, Coates AS, Goldhirsch A.
Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: Combined
results of 15 International Breast Cancer Study Group Clinical Trials. J Clin Oncol 2008;
26(18):3006-3014.
720.
Pestalozzi BC, Francis P, Quinaux E, Dolci S, Azambuja E, Gelber RD, Viale G, Balil A, Andersson
M, Nordenskjöld B, Gnant M, Gutierrez J, Láng I, Crown JPA, Piccart-Gebhart M on behalf of the
BIG 02-98 Collaborative Group. Is risk of central nervous system (CNS) relapse related to adjuvant
taxane treatment in node-positive breast cancer? Results of the CNS substudy in the intergroup
phase III BIG 02-98 trial. Ann Oncol 2008; 19:1837-1841.
721.
Rasmussen, BB, Regan MM, Lykkesfeldt AE, Dell’Orto P, Del Curto B, Henriksen KL,
Mastropasqua MG, Price KN, Méry E, Lacroix-Triki M, Braye S, Altermatt HJ, Gelber RD,
Castiglione-Gertsch M, Goldhirsch A, Gusterson BA, Thürlimann B, Coates AS, Vaile G, for the
BIG 1-98 Collaborative and International Breast Cancer Study Groups. Adjuvant letrozole versus
tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with
endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised
trial. Lancet Oncol 2008; 9:23-28.
722.
Ravaioli A, Monti F, Regan MM, Maffini F, Mastropasqua MG, Spataro V, Castiglione-Gertsch
M, Panzini I, Gianni L, Goldhirsch A, Coates AS, Price KN, Gusterson BA, Viale G, for the
International Breast Cancer Study Group. p27 and Skp2 immunoreactivity and its clinical
significance with endocrine and chemo-endocrine treatments in node-negative early breast
cancer. Ann Oncol 2008; 19:660-668.
723.
Regan MM, Pagani O, Walley B, Torrisi R, Perez EA, Francis P, Fleming GF, Price KN, Thürlimann
B, Maibach R, Castiglione-Gertsch M, Coates AS, Goldhirsch A, Gelber RD for the SOFT/TEXT/
PERCHE Steering Committee and the International Breast Cancer Study Group. Premenopausal
endocrine-responsive early breast cancer: Who receives chemotherapy? Ann Oncol 2008;
19:1231-1241.
724.
Sestak I, Cuzick J, Sapunar F, Eastell R, Forbes JF, Bianco AR, Buzdar AU, on behalf of the ATAC
Trialists’ Group. Risk factors for joint symptoms in patients enrolled in the ATAC trial: retrospective,
exploratory analysis. Lancet Oncol 2008; 9:866-872.
725.
Sestak I, Forbes JF, Edward R, Howell A, Cuzick J. Timing and severity of prominent side effects
of anastrozole and tamoxifen. Eur J Cancer Supplements 2008; 6(7):71, Poster 73.
87
726.
Untch M, Gelber RD, Jackisch C, Procter M, Baselga J, Bell R, Cameron D, Bari M, Smith
I, Leyland-Jones B, de Azambuja E, Wermuth P, Khasanov R, Feng-yi F, Constantin C,
Mayordomo JI, Su-CH, Yu SY, Lluch A, Senkus-Konefka E, Price C, Haslbauer F, Suarez Sahui T,
Srimuninnimit V, Colleoni M, Coates AS, Piccart-Gebhart MJ, Goldhirsch A, for the HERA Study
Team. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA
Trial. Ann Oncol 2008; 19:1090-1096.
727.
Viale G, Giobbie-Hurder A, Regan MM, Coates AS, Mastropasqua MG, Dell’Orto P, Maiorano E,
MacGrogan G, Braye SG, Öhlschlegel C, Neven P, Orosz Z, Olsewski WP, Knox F, Thürlimann
B, Price KN, Castiglione-Gertsch M, Gelber RD, Gusterson BA, Goldhirsch A. Prognostic and
predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with
endocrine-responsive breast cancer: results from Breast International Group Trial 1-98 comparing
adjuvant tamoxifen with letrozole. J Clin Oncol 2008; 26(34):5569-5575.
728.
Viale G, Regan MM, Maiorano E, Mastropasqua MG, Golouh R, Perin T, Brown RW, Kovács
A, Pillay K, Öhlschlegel C, Braye S, Grigolato P, Rusca T, Gelber RD, Castiglione-Gertsch M,
Price KN, Goldhirsch A, Gusterson BA, Coates AS. Chemoendocrine compared with endocrine
adjuvant therapies for node-negative breast cancer: predictive value of centrally reviewed
expression of estrogen and progesterone receptors - International Breast Cancer Study Group.
J Clin Oncol 2008; 26(9):1404-1410.
729.
Viale G, Regan MM, Mastropasqua MG, Maffini F, Maiorano E, Colleoni M, Price KN, Golouh
R, Perin T, Brown RW, Kovács A, Pillay K, Öhlschlegel C, Gusterson BA, Castiglione-Gertsch
M, Gelber RD, Goldhirsch A, Coates AS. Predictive value of tumor Ki-67 expression in two
randomized trials of adjuvant chemoendocrine therapy for node-negative breast cancer. J Natl
Cancer Inst 2008; 100:207-212.
730.
Wapnir IL, Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Mamounas EP, Wolmark N.
Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating
chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg
Oncol 2008; 15(11):3227-3231.
731.
Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J,
Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark
N. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse
of breast cancer: IBCSG 27-02, BIG 1-02, NSABP B-37. Clin Breast Cancer 2008; 8:287-292.
01/01/2009 to 31/03/2009
732.
Bonetti M, Zahrieh D, Cole BF, Gelber RD. A small sample study of the STEPP approach to assessing
treatment-covariate interactions in survival data. Statistics in Medicine 2009; 28:1255-1268.
733.
Dowsett M, Cuzick J, Wales C, Forbes J, Mallon L, Salter J, Quinn E, Bugarini R, Baehner FL,
Shak S and on behalf of the ATAC Trialists’ Group. Risk of distant recurrence using oncotype
DX in postmenopausal primary breast cancer patients treated with anastrozole or tamoxifen: a
TransATAC study. Cancer Research 2009; 69 (2 Supplement):53.
734.
Dowsett M, Procter M, McCaskill-Stevens W, de Azambuja E, Dafni U, Rueschoff J, Jordan
B, Dolci S, Abramovitz M, Stoss O, Viale G, Gelber RD, Piccart-Gebhart M, Leyland-Jones
B. Disease-free survival according to degree of HER2 amplification for patients treated with
adjuvant chemotherapy with or without 1 year of trastuzumab: The HERA Trial. J Clin Oncol 2009;
27(18):2962-2969.
735.
Gianni L, Gelber S, Ravaioli A, Price KN, Panzini I, Fantini M, Castiglione-Gertsch M, Pagani O,
Simoncini E, Gelber RD, Coates AS, Goldhirsch A. Second non-breast primary cancer following
adjuvant therapy for early breast cancer: A report from the International Breast Cancer Study
Group. Eur J Cancer 2009; 45:561-571.
736.
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 2009; Published
online: 12 March 2009.
737.
Mouridsen HT, Giobbie-Hurder A, Mauriac L, Paridaens R, Colleoni M, Thürlimann B, Forbes JF,
Gelber RD, Wardley A, Smith I, Price KN, Coates A, Goldhirsch A and the International Breast
Cancer Study Group. BIG 1-98: A randomized double-blind phase III study evaluating letrozole
and tamoxifen given in sequence as adjuvant endocrine therapy for postmenopausal women with
receptor-positive breast cancer. Cancer Research 2009; 69 (2 Supplement):13.
738.
Pagani O, Gelber S, Simoncini E, Castiglione-Gertsch M, Price KN, Gelber RD, Holmberg
SB, Crivellari D, Collins J, Lindtner J, Thürlimann B, Fey MF, Murray E, Forbes JF, Coates AS,
Goldhirsch A for the International Breast Cancer Study Group. Is adjuvant chemotherapy of
benefit for postmenopausal women who receive endocrine treatment for highly endocrineresponsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and
12-93. Breast Cancer Res Treat 2009; 116:491-500.
739.
Ruhstaller T, von Moos R, Rufibach K, Ribi K, Glaus A, Spaeti B, Koeberle D, Mueller U, Hoefliger
M, Hess D, Boehme C, Thürlimann B. Breast Cancer patients on endocrine therapy reveal more
symptoms when self-reporting than in pivotal trials: an outcome research study. Oncology 2009;
76:142-148.
740.
Sun Z, Goldhirsch A, Price KN, Colleoni M, Ravaioli A, Simoncini E, Campbell I, Gelber RD, Towler
M. Bone Quality Test (BQT) scores of fingernails in postmenopausal patients treated with adjuvant
letrozole or tamoxifen for early breast cancer. The Breast 2009; 18:84-88.
741.
Thürlimann B, Price KN, Gelber RD, Holmberg SB, Crivellari D, Colleoni M, Collins J, Forbes JF,
Castiglione-Gertsch M, Coates AS, Goldhirsch A. Is chemotherapy necessary for premenopausal
women with lower-risk node-positive, endocrine-responsive breast cancer? 10-year update of
International Breast Cancer Study Group Trial 11-93. Breast Cancer Res Treat 2009; 113:137-144.
89
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.
ANZ BCTG: Australian New Zealand Breast Cancer Trials Group.
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.
BIG: Breast International Group.
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’.
CIRG: Cancer International Research Group.
CLINICAL TRIAL: Research conducted with the patient’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.
CRUK: Cancer Research U.K.
DUCTAL CARCINOMA IN SITU (DCIS): Abnormal cells in the breast ducts, which over time could develop into invasive
breast cancer.
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.
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.
GOOD CLINICAL PRACTICE (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, 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.
91
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 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. 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.
HUMAN RESEARCH ETHICS COMMITTEE (HREC): The Human Research Ethics Committee’s function is to review
proposed research in order to insure that the subject’s rights are protected and that risk of harm is minimised.
IBCSG: International Breast Cancer Study Group.
INDEPENDENT DATA SAFETY AND MONITORING COMMITTEE (IDSMC): An independent group of experts or
adequately qualified individuals who monitor patient 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 Patient Information Sheet and any associated materials.
LOCALLY ADVANCED BREAST CANCER: Is 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
■■ 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.
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.
MORBIDITY: The relative incidence of a particular disease within a defined population.
NEOADJUVANT: Treatment given to the cancer patient prior to surgery or further treatment.
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.
NSABP: National Surgical Adjuvant Breast and Bowel Project.
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.
ONCOLOGIST: A doctor who specialises in treating cancer.
ONCOLOGY: A branch of medicine that deals with cancer.
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.
PARTICIPATING INSTITUTION: Any public or private hospital or facility where ANZ BCTG clinical trials are conducted.
PATIENT INFORMATION SHEET: A document designed to provide patients with relevant information and facts relating
to the proposed clinical trial in order for the patient to make an informed decision regarding their participation in the trial.
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 ANZ BCTG
participating institution level; 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.
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 patients, 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.
RADIOTHERAPY: The use of radiation, usually x-rays or gamma rays, to kill cancer cells or damage them so they
cannot grow and multiply.
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.
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 on hormonesensitive breast cancers.
93
SENTINEL NODE: Is 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 ANZ BCTG 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 ANZ BCTG participating institution who takes
responsibility for non-clinical aspects associated with the conduct of a clinical trial.
SWOG: SouthWest Oncology Group – US.
SYSTEMIC ADJUVANT THERAPY: The use of chemotherapy, hormone therapy and/or targeted therapy or a
combination of these, given after surgery 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.
TYROSINE KINASE INHIBITOR (example: lapatinib): A drug that interferes with cell communication and growth and
which may prevent tumour growth.
Yes, I want to support breast cancer research…
You can donate online at www.bcia.org.au, or complete your details below and
send to the postal address shown or fax it to 02 4925 3068.
Postal Address: PO Box 283, The Junction NSW 2291 Australia
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AR2008-2009
95

Celebrating 30 years - Breast Cancer Institute of Australia

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