What are breast cancer clinical trials?

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What are breast cancer

clinical trials?

Australia & New Zealand Breast Cancer Trials Group PO Box 283

The Junction NSW 2291 Australia Ph: +61 2 4925 5255 Fax: +61 2 4925 3068 Email: enquiries@anzbctg.org Breast Cancer Institute of Australia

PO Box 283

The Junction NSW 2291 Australia Ph: 02 4925 3022 Fax: 02 4925 3068 Email: enquiries@bcia.org.au

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Clinical trials by their nature are expensive to conduct as they can take some years from development to recruitment, then to analysis, publication and translation into community benefit. In 1994, the ANZBCTG established a dedicated fundraising department, the Breast Cancer Institute of Australia (BCIA).

The BCIA conducts a number of fundraising activities in Australia. Funds raised ensure ANZBCTG researchers can conduct high quality clinical trials which can lead to more treatment options and more lives saved from breast cancer.

Many thousands of individuals,

several well-known corporate identities and a number of

community groups and organisations are committed

through the BCIA to funding the important clinical trials

undertaken by the ANZBCTG.

The Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) is the largest independent,

oncology clinical trials research group in Australia and New Zealand. For more than 35 years, it has conducted a 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 700 researchers in more than 80 institutions throughout Australia and New Zealand. This collaboration ensures that knowledge is shared, resources are pooled and progress is faster.

More than 14,000 women from Australia and New Zealand have participated in ANZBCTG clinical trials.

Professor Stephen Ackland is the Chair of the ANZBCTG Board of Directors. page 3 page 2 *

About Us

Catherine Braley (left) and Christine Plunkett raising funds for BCIA

at the Bridge to Brisbane fun run.

FACT

One in eight women

in Australia will

be diagnosed with

breast cancer by

the age o

f 85.

(4)

Clinical trials are an important aspect of developing new and improved health care initiatives.

Breast cancer clinical trials are designed to answer scientific questions, which may result in the identification of new and improved treatment options and preventative therapies.

Case Study: The International

Breast cancer Intervention Study – IBIS-I & IBIS-II.

In the IBIS-I clinical trial it was proven that tamoxifen reduced the risk of developing hormone-sensitive breast cancer by about one third in women at increased risk of breast cancer. These benefits continued for at least another five years after treatment with tamoxifen had stopped. In the follow up clinical trial IBIS-II, it was found that taking the drug anastrozole for five years reduced the chances of postmenopausal women at high risk of breast cancer developing the disease by 53%. These results could offer a new option for preventing breast cancer in moderate to high risk postmenopausal women which is more effective than tamoxifen and has fewer side effects.

Professor John Forbes AM with Tania (left) and Lynette who are participants in

the IBIS-I and IBIS-II clinical trials.

Clinical trials are necessary to find out if new treatments are more effective than those currently accepted as the best available standard treatment.

All of the major milestones in controlling breast cancer worldwide have come through clinical trials. These include:

• Chemotherapy and hormone treatment prevents recurrence and saves lives;

• Mammograms save lives through earlier detection;

• Removing just the cancer and preserving the breast is a safe and effective treatment for most women;

• Breast cancer can be prevented in some women at increased risk; • Treatments targeted to the specific type of breast cancer can improve outcomes substantially.

All new treatments and procedures must be scientifically proven through clinical trials research before they can be adopted as standard treatment for women diagnosed with breast cancer.

Why

Have

Clinical

Trials?

What

Are Breast

Cancer

Clinical

Trials?

* *

FACT

About 40 women

are diagnosed with

breast cancer

each day.

FACT

Breast cancer is

the most common

cancer among

women in Australia.

(5)

page 7 page 6

Why

Participate

In A Clinical

Trial?

Katy’s Story

Katy was diagnosed with HER2 positive breast cancer in December 2012 and is a participant in the APHINITY clinical trial.

As a Clinical Personal Assistant to a group of surgeons, Katy was used to being on the “other side” of a cancer diagnosis, helping other people to cope with their situation. Katy’s clinical experience also meant she was aware of clinical trials research and understood how and why they were conducted.

“Joining the clinical trial felt like something I should do and I have faith that the trial participant results might benefit me and other women in the future who are diagnosed with HER2 positive breast cancer,” Katy said.

Katy is a clinical trial participant and is

pictured with Dr Janine Lombard.

People take part in clinical trials for many reasons including: • They may be able to access a new treatment before it is routinely available as standard treatment for all breast

cancer patients;

• The treatments offered on a clinical trial include the best current standard treatment, compared with a new treatment which earlier research shows may be better; • Participating in a clinical trial helps to advance

medical knowledge;

• Many clinical trial participants are motivated to take part because the results of current clinical trials may help improve treatments and outcomes for future women diagnosed with breast cancer or who are at risk.

Clinical trial participants may be monitored more closely than patients who receive standard treatment and their treatment is rigorously documented. There are usually questionnaires to complete regarding the participant’s feelings or reactions to the treatment. This careful follow up means that the outcomes of the clinical trial are the result of accurate and detailed information which is then published in peer reviewed scientific journals.

FACT

This year, 1,000

more women will

survive their breast

cancer diagnosis

compared to

20 years ago.

FACT

The mortality rate

for breast cancer

has fallen by more

than 29% in the

last 20 years.

*

(6)

The guiding document for the conduct of a clinical trial is called a protocol. Clinical trial protocols are written

by experienced clinicians and a team of experts in breast cancer treatment, translational research and trials coordination. All clinical trials conducted by the ANZBCTG are monitored by the ANZBCTG Scientific Advisory Committee.

The clinical trial protocol outlines the reason for doing the study, who may participate, the treatments and tests involved, when these will be done and why. The protocol must be approved by an independent panel of scientists, medical professionals and consumers, called an ethics committee. The progress of the clinical trial and the safety of clinical trial participants is carefully reviewed and monitored by an Independent Data and Safety Monitoring Committee and by the ethics committee responsible for approving the clinical trial.

Before joining a clinical trial, potential participants must understand why the clinical trial is being conducted, the potential risks and benefits and what their involvement would include. The decision to participate is made on the basis of information provided to the patient by her treating doctor. Written information about the clinical trial will also be provided.

Both the doctor and the potential participant must be satisfied that all information about the clinical trial is understood and a statement to this effect is signed by both parties. This process is called “obtaining informed consent to participate in a clinical trial”.

There are many types of clinical trials for the prevention and treatment of breast cancer, and studies which aim to improve a patient’s quality of life. Prevention clinical trials are designed to test new strategies to prevent breast cancer for women who have never had the disease but who are at high risk.

Treatment clinical trials are designed to find out which treatments are the most effective and to test new treatments to see if they are better at improving outcomes for patients compared to the current standard treatments available.

Quality of life assessments pay special attention to the breast cancer patient’s feelings about the impact and side effects of treatment. The aim of these assessments is to look for ways to improve the overall experience of the patients who receive these treatments in the future. The ANZBCTG has pioneered the measurement of quality of life in patients and carried out this research for more than 30 years.

IBIS-II participant Tania is pictured with

Nurse Coordinator Yvonne Harrower.

Are

Clinical

Trials

Safe?

Are There

Different

Types Of

Clinical

Trials?

(7)

If you would like to participate in a clinical trial you should discuss this with your treating doctor.

A list of ANZBCTG clinical trials that are open for participant entry is available at www.anzbctg.org. Information about breast cancer clinical trials can also be found on the Australian New Zealand Clinical Trials Registry website at www.anzctr.org.au.

page 10 page 11

How Can

I Take

Part In A

Clinical Trial?

Nurse Coordinator Vicki Sproule is pictured

with Alison who was a clinical trial participant.

There are more than 700 ANZBCTG members, representing over 80 institutions throughout Australia and New Zealand.

Our membership includes: surgeons; medical

oncologists; study coordinators; radiation oncologists; pathologists; endocrinologists; haematologists; pharmacists; geneticists; psychologists; counsellors; data managers; research nurses; consumers and other clinical trials management personnel.

ANZBCTG members are representatives on many national and international clinical trial steering committees, scientific committees, editorial boards, advisory boards and societies.

The ANZBCTG’s international collaboration extends to 15 countries and includes other leading international clinical trials groups such as the Breast International Group (Belgium), Cancer Research UK, the

German Breast Group and the International Breast Cancer Study Group (Switzerland and USA).

Collaboration

NEW ZEALAND AUSTRALIA WA NT QLD NSW VIC SA TAS Participating ANZBCTG Institutions

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The ANZBCTG Consumer Advisory Panel (CAP) was established in 1998 to recognise the value and

importance of consumer input to the planning and conduct of clinical trials research.

The input and insights provided by CAP members, most of whom have participated in an ANZBCTG clinical trial, are integral to the research program of the ANZBCTG. CAP members help to ensure a consumer perspective is provided from the very early planning stage of ANZBCTG clinical trial development. CAP aims to:

• advocate for women who may be participating, or who have participated, in ANZBCTG breast cancer clinical trials;

• provide the ANZBCTG with a consumer perspective on relevant issues about clinical trials including recruitment, patient information materials, new clinical trial protocols and potential ethical issues;

• raise community awareness of breast cancer clinical trials and research; and

• represent consumer views on behalf of the ANZBCTG in government, community, consumer and research forums to promote the importance of clinical trials research.

The

Consumer

Advisory

Panel

CAP Members L-R: Leslie Gilham, Cheryl Grant, Carol Whiteside, Leonie Young (Chair),

Sheryl Fewster and Raewyn Calvert.

(Absent: Linda Reaby)

Useful Websites

Australia

Australian Clinical Trials www.australianclinicaltrials.gov.au

Australian New Zealand Clinical Trials Registry www.anzctr.org.au

Breast Cancer Institute of Australia www.bcia.org.au

Breast Cancer Network Australia www.bcna.org.au

BreastScreen Australia www.cancerscreening.gov.au

Cancer Australia www.canceraustralia.gov.au

Cancer Council Australia www.cancer.org.au

Clinical Oncological Society of Australia (COSA) www.cosa.org.au

National Health and Medical Research Council (NHMRC) www.nhmrc.gov.au

Therapeutic Goods Administration www.tga.gov.au

New Zealand

Breastscreen Aotearoa www.nsu.govt.nz/current-nsu-programmes/ breastscreen-aotearoa.aspx

Breast Cancer Aotearoa Coalition www.breastcancer.org.nz

Cancer Society of New Zealand www.cancernz.org.nz

Cancer Trials New Zealand www.fmhs.auckland.ac.nz/sms/oncology/ctnz/

New Zealand Association of Clinical Research www.nzacres.org.nz

New Zealand Ministry of Health, Health Tumour Standards www.health.govt.nz

Waikato Breast Cancer Trust www.wbct.org.nz

International

ClinicalTrials.gov www.clinicaltrials.gov

National Cancer Institute, United States www.cancer.gov

EU Clinical Trials Register (EU-CTR) www.clinicaltrialsregister.eu *_{Facts Source:}

Australian Institute of Health and Welfare & Cancer Australia. 2012. Breast Cancer in Australia: An Overview.

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Australia & New Zealand Breast Cancer Trials Group PO Box 283

The Junction NSW 2291 Australia Ph: +61 2 4925 5255 Fax: +61 2 4925 3068 Email: enquiries@anzbctg.org Breast Cancer Institute of Australia

PO Box 283

The Junction NSW 2291 Australia Ph: 02 4925 3022 Fax: 02 4925 3068 Email: enquiries@bcia.org.au

The Australia & New Zealand Breast Cancer Trials Group is supported by its fundraising department the

Breast Cancer Institute of Australia.

What are breast cancer clinical trials?