What are breast cancer clinical trials?

Transcription

1 What are breast cancer clinical trials?

2 Contents About Us...2 Breast Cancer Institute Of Australia...3 What Are Breast Cancer Clinical Trials?...4 Why Have Clinical Trials?...5 Why Participate In A Clinical Trial?...6 Katy s Story...7 Are Clinical Trials Safe?...8 Are There Different Types Of Clinical Trials?...9 How Can I Take Part In A Clinical Trial?...10 Collaboration Consumer Advisory Panel enquiries@anzbctg.org Useful Websites...13 Web: or scan the following QR code: page 1

3 About Us 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. Catherine Braley (left) and Christine Plunkett raising funds for BCIA at the Bridge to Brisbane fun run. 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. 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. One in eight women in Australia will be diagnosed with breast cancer by the age of 85. * 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. page 2 page 3

4 What Are Breast Cancer Clinical Trials? 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. 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: Why Have Clinical Trials? Chemotherapy and hormone treatment prevents recurrence and saves lives; Mammograms save lives through earlier detection; Professor John Forbes AM with Tania (left) and Lynette who are participants in the IBIS-I and IBIS-II clinical trials. 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. 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. Breast cancer is the most common cancer among women in Australia. * About 40 women are diagnosed with breast cancer each day. * page 4 page 5

5 People take part in clinical trials for many reasons including: Why Participate In A Clinical Trial? 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. 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. page 6 This year, 1,000 more women will survive their breast cancer diagnosis compared to 20 years ago. The mortality rate for breast cancer has fallen by more than 29% in the last 20 years.* Katy is a clinical trial participant and is pictured with Dr Janine Lombard. page 7

6 Are Clinical Trials Safe? 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 Are There Different Types Of Clinical Trials? 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. IBIS-II participant Tania is pictured with Nurse Coordinator Yvonne Harrower. 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. page 8 page 9

7 If you would like to participate in a clinical trial you should There are more than 700 ANZBCTG members, How Can I Take Part In A Clinical Trial? discuss this with your treating doctor. A list of ANZBCTG clinical trials that are open for participant entry is available at Information about breast cancer clinical trials can also be found on the Australian New Zealand Clinical Trials Registry website at 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 Collaboration 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. Participating ANZBCTG Institutions NT WA QLD SA NSW AUSTRALIA VIC Nurse Coordinator Vicki Sproule is pictured with Alison who was a clinical trial participant. NEW ZEALAND 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). page 10 page 11 TAS

8 The Consumer Advisory Panel CAP aims to: 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. advocate for women who may be participating, or who have participated, in ANZBCTG breast cancer clinical trials; Useful Websites Australia Australian Clinical Trials Australian New Zealand Clinical Trials Registry Breast Cancer Institute of Australia Breast Cancer Network Australia BreastScreen Australia Cancer Australia Cancer Council Australia Clinical Oncological Society of Australia (COSA) National Health and Medical Research Council (NHMRC) Therapeutic Goods Administration page 12 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. CAP Members L-R: Leslie Gilham, Cheryl Grant, Carol Whiteside, Leonie Young (Chair), Sheryl Fewster and Raewyn Calvert. (Absent: Linda Reaby) New Zealand Breastscreen Aotearoa Breast Cancer Aotearoa Coalition Cancer Society of New Zealand Cancer Trials New Zealand New Zealand Association of Clinical Research New Zealand Ministry of Health, Health Tumour Standards Waikato Breast Cancer Trust International ClinicalTrials.gov National Cancer Institute, United States EU Clinical Trials Register (EU-CTR) breastscreen-aotearoa.aspx * Facts Source: Australian Institute of Health and Welfare & Cancer Australia Breast Cancer in Australia: An Overview.

9 The Australia & New Zealand Breast Cancer Trials Group is supported by its fundraising department the Breast Cancer Institute of Australia. Australia & New Zealand Breast Cancer Trials Group PO Box 283 The Junction NSW 2291 Australia Ph: Fax: enquiries@anzbctg.org Breast Cancer Institute of Australia PO Box 283 The Junction NSW 2291 Australia Ph: Fax: enquiries@bcia.org.au