Launch January 2008

From the press release :

"The trial will compare women’s responses to the platinum-based drug, carboplatin, not normally used to treat breast cancer, with responses to docetaxel, the current standard treatment for hormone and HER2 negative tumours. Eligible patients will be randomly allocated to receive one of the two treatments and patients will be followed to determine whether carboplatin is a more effective treatment for hormone and HER2 negative breast cancer.

The trial is open to women who have hormone and HER2 negative breast cancer which has spread to another part of the body after treatment. It is hoped that up to 450 women from hospitals in the UK will take part over a five year period. "

The full press release is at the bottom of this page.

At the launch in January, Breakthrough Breast Cancer showed a video of individuals disgnosed with triple negative breast cancer describing why this kind of trial is so important. This is an excerpt from this video.

Video ©2008 Breakthrough Breast Cancer

Press Release from Breakthrough Breast Cancer

"Cancer charities join forces to launch new trial for women with an aggressive type of breast cancer

Two of the UK’s leading cancer charities, Breakthrough Breast Cancer and Cancer Research UK, have launched the first UK-based clinical trial for women with an aggressive form of breast cancer which has spread to another part of the body. The Triple Negative Trial aims to improve breast cancer treatment for women with hormone and HER2 negative tumours, sometimes referred to as “triple negative” because they lack hormone (oestrogen and progesterone) and HER2 receptors. They are more common amongst younger women and those of African ethnicity.

Breast cancer is the most common cancer in the UK with over 44,000 women diagnosed each year. “Triple negative” tumours account for 15% to 20% of all breast cancers in the UK and, although more common in women of African ethnicity, most breast cancers of this type occur in Caucasian women in the UK due to the demographics of the country’s population.

Hormone and HER2 negative tumours do not respond to targeted treatments like Herceptin or hormone therapies such as tamoxifen and because of this, can be hard to treat. The Breakthrough Breast Cancer and Cancer Research UK Triple Negative Trial aims to develop a more tailored and effective chemotherapy treatment for women with hormone and HER2 negative breast cancer, which has spread elsewhere in the body.

The trial will compare women’s responses to the platinum-based drug, carboplatin, not normally used to treat breast cancer, with responses to docetaxel, the current standard treatment for hormone and HER2 negative tumours. Eligible patients will be randomly allocated to receive one of the two treatments and patients will be followed to determine whether carboplatin is a more effective treatment for hormone and HER2 negative breast cancer.

The trial is open to women who have hormone and HER2 negative breast cancer which has spread to another part of the body after treatment. It is hoped that up to 450 women from hospitals in the UK will take part over a five year period.

Dr Andrew Tutt, Director of the new Breakthrough Breast Cancer Research Unit at King’s College London and Consultant oncologist at Guy’s and St Thomas’ NHS Foundation Trust, is leading the trial. Dr Tutt said;

“Due to its nature, hormone and HER2 negative, or ”triple negative”, breast cancer does not respond to targeted treatments like tamoxifen or Herceptin. Women with these tumours face standard chemotherapy, which does not target the specific biology of this type of cancer. Ultimately, we hope carboplatin could become part of a new, standard treatment for patients with hormone and HER2 negative breast cancer.”

Breakthrough Breast Cancer and Cancer Research UK are jointly funding the Triple Negative Trial. Kate Law, Cancer Research UK’s director of clinical trials, said:

“Women who have the kind of breast cancer that does not respond to tamoxifen or other hormone treatment may feel they are a neglected group. Clinical trials like this are vital in helping us to develop more effective treatments and improve survival rates for this type of breast cancer.”

This work builds on groundbreaking research which took place at the Breakthrough Breast Cancer Research Centre at The Institute of Cancer Research and Guy’s Hospital in London. Scientists found the BRCA1 gene is ‘turned off’ in some “triple negative” cancers, making this type of tumour act in a similar way to some hereditary breast cancers where the BRCA1 gene is damaged. Scientists have also shown that platinum-based drugs like carboplatin are more effective than other chemotherapy drugs in killing cancer cells with faulty BRCA genes. Because of this, scientists hope carboplatin will be an effective treatment for women with hormone and HER2 negative breast cancer.

The Triple Negative Trial is being co-ordinated by The Institute of Cancer Research’s Clinical Trials and Statistics Unit (ICR-CTSU) which specialises in large studies of breast cancer treatments. Professor Judith Bliss, Director of The Cancer Research UK Clinical Trials and Statistics Unit at The Institute of Cancer Research said;

“The Triple Negative Trial is an exciting development in the translation of cutting-edge research into real life clinical practice for breast cancer patients throughout the UK. We hope this trial will help to better target cancer treatments to the needs of individual patients.”

36-year-old Sam Hills from London was diagnosed with hormone and HER2 negative breast cancer in 2006. She says; “It was a real shock to be diagnosed with breast cancer because I thought it only happened to older women. I didn’t really know what it meant to have hormone and HER2 negative breast cancer and it’s scary to think that general chemotherapy is all there is to treat it. I welcome any trials to improve treatment for women with triple negative breast cancer.”

To find out more about the Triple Negative Trial, please visit the Breakthrough Breast Cancer website; www.breakthrough.org.uk or Cancer Research UK’s clinical trials database; www.cancerhelp.org.uk.

-Ends-

Notes to Editors

• Hormone and HER2 negative breast cancers lack oestrogen receptors (ER), progesterone receptors (PR) and human epidermal growth factor receptor-two (HER2). Because of this, hormone and HER2 negative breast cancers are often referred to as ”triple negative”.
  
• Hormone and HER2 negative breast cancers are more aggressive than other types of tumours and do not respond to hormone treatments like tamoxifen or targeted treatments like Herceptin because they lack the hormone and HER2 receptors which these treatments target.
  
• The Triple Negative Trial is a Phase III clinical trial. This means the treatment is given to large groups of people to check its effectiveness, safety, side-effects, compare it to other standard drugs or treatments and gather other information that will allow it to be used safely. These trials often take several years to complete and this trial is expected to last 5 years.
  
• This trial is being run through The Institute of Cancer Research Clinical Trials and Statistics Unit. Any clinicians interested in finding out more about the trial should contact their local NCRN manager or email tnt-icrctsu@icr.ac.uk
  
  
• Dr Andrew Tutt is the Chief Investigator of the Triple Negative Trial. Dr Tutt is a Consultant oncologist at Guy’s and St Thomas’ NHS Foundation Trust and Director of the new Breakthrough Breast Cancer Research Unit at King’s College London, which is based in Guy's Hospital, part of Guy's and St Thomas' NHS Foundation Trust
  
• Breakthrough Breast Cancer and Cancer Research UK are jointly funding this trial and it is also sponsored by The Institute of Cancer Research and King’s College London.
  

Breakthrough Breast Cancer:

• Breakthrough Breast Cancer is the UK’s leading charity committed to fighting breast cancer through research, campaigning and education. Our essence comes from the thousands of people who are committed to a single vision - to work for a future free from the fear of breast cancer. More information can be found at: www.breakthrough.org.uk or through the Breakthrough Information Line 08080 100 200.
  
• In 1999, Breakthrough Breast Cancer, in partnership with The Institute of Cancer Research, established the UK's first dedicated breast cancer research centre - The Breakthrough Toby Robins Breast Cancer Research Centre.
  
• The Breakthrough Toby Robins Breast Cancer Research Centre is situated in the Mary-Jean Mitchell Green Building at the Chester Beatty Laboratories at The Institute of Cancer Research. It is the first dedicated breast cancer research facility in the UK and, under the directorship of Professor Alan Ashworth, its 120 scientists and clinicians are working on a programme of cutting edge biological research that ultimately aims to eradicate breast cancer, by discovering the causes of the disease, finding methods of prevention and developing new treatments and more effective diagnosis.
  
• During 2008, Breakthrough Breast Cancer will open three new research units in Edinburgh, Manchester and London to investigate ways to prevent breast cancer and improve diagnosis and treatments for the disease. They will complement existing research currently being undertaken at the Breakthrough Breast Cancer Research Centre.
  

Cancer Research UK:

• Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.
• Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.
• Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.
• Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.
• Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.
• For further information about Cancer Research UK's work or to find out how to support the charity, please call 020 7009 8820 or visit www.cancerresearchuk.org

The Institute of Cancer Research Clinical Trials Statistics Unit (ICR-CTSU):

• The Institute of Cancer Research’s Clinical Trials and Statistics Unit (ICR-CTSU) is an academic clinical trials unit accredited by the National Cancer Research Institute (NCRI) to conduct clinical trials into cancer treatments. The department is funded by an infrastructure grant from Cancer Research UK. Trial website: www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/7574_disease.shtml
  
  
• The Institute of Cancer Research is Europe's leading cancer research centre with expert scientists working on cutting edge research. It was founded in 1909 to carry out research into the causes of cancer and to develop new strategies for its prevention, diagnosis, treatment and care. Website: www.icr.ac.uk.

Breast Cancer:

• Breast cancer is now the most common cancer in the UK, accounting for nearly 1 in 3 of all female cancers.
• Over 44,000 women are diagnosed with breast cancer every year in the UK and 1,000 women will die every month from this disease.
• Breakthrough has developed a BMA patient information award-winning booklet, Breast Cancer Risk Factors: The Facts – which summarises what is currently known about the factors that affect breast cancer risk.
  Please call 08080 100 200 for a free copy. "
  
  For more information click here : http://www.breakthrough.org.uk/what_we_do/whats_new/triple_negative.html

All the content of this page is copyright ©2008 Breakthrough Breast Cancer and reproduced with their kind permission.