$5.9 MILLION IN NHMRC GRANTS FOR TWO INNOVATIVE TRIALS

• BRCA-P: The first international clinical trial of breast cancer prevention in BRCA1 mutation carriers
• CAPTURE: The first clinical trial to assess the role of circulating tumour DNA testing to improve outcomes for women with metastatic breast cancer

The National Health and Medical Research Council (NHRMC) has awarded $5.9 million to two innovative breast cancer clinical trials which will be conducted in Australia by Breast Cancer Trials.

The BRCA-P clinical trial will be the first international study of breast cancer prevention in women with a faulty BRCA1 gene and has received an NHMRC grant of $2.6M. The study will test the drug denosumab, to see if it will safely and effectively reduce the incidence of breast cancer in BRCA1 mutation carriers, who have a high lifetime risk of developing breast and ovarian cancer. Previous research identified cells that give rise to breast cancer in women with a faulty BRCA1 gene and found that denosumab may be able to switch off these cells before they become cancerous.

The prevalence of BRCA1 mutations is believed to be approximately 1:800, which equates to 15,000 Australian women who are at high risk of developing breast cancer by the age of 80. The trial will recruit women with the BRCA1 mutation, who are aged 25 to 55, and are breast and ovarian cancer free. If positive, this would be the first drug shown to prevent ER-negative breast cancer. The Study Chair of BRCA-P is Professor Geoffrey Lindeman.

“These women have a 70% life-time risk of developing breast cancer, with few prevention options available beyond bilateral mastectomy. Through NHMRC funding and the expertise provided by Breast Cancer Trials, we will be able to determine whether we can safely and effectively prevent or delay breast cancer in this ‘high-risk’ group,” said Professor Lindeman.

The CAPTURE clinical trial is aimed at improving progression free survival rates for women with metastatic breast cancer that is ER positive and HER2 negative and has received an NHRMC grant of $3.3M. Molecular approaches to cancer treatment, such as the analysis of cell free circulating tumour DNA (ctDNA), are opening up opportunities to guide the delivery of targeted therapy to those patients most likely to benefit. This will be the first prospective randomised clinical trial to assess the role of PIK3CA mutant ctDNA testing, as a predictive biomarker. The study will determine if women who test positive for the PIK3CA mutant through ctDNA testing, will benefit from treatment with the PI3 kinase inhibitor alpelisib.

If successful, the trial will be an important step towards demonstrating the clinical utility of circulating tumour DNA testing in women with ER positive metastatic breast cancer. The Study Chair of CAPTURE is Associate Professor Sarah-Jane Dawson.

“Rapid progress has been made in the development of ctDNA tests for use in cancer management. This trial will provide an important opportunity to understand how these tests may benefit women with metastatic breast cancer and hopefully bring us a step closer to routine incorporation of ctDNA testing in clinical practice,” said Associate Professor Dawson.

It is expected that both BRCA-P and CAPTURE will open to participant entry in early to mid-2018.

Breast Cancer Trials is the largest, independent, oncology clinical trials research group in Australia and New Zealand. For almost 40 years, Breast Cancer Trials has conducted a national clinical trials research program for the treatment, prevention and cure of breast cancer. For more information about Breast Cancer Trials, visit www.breastcancertrials.org.au.

A full list of NHMRC grant recipients is available on the NHMRC website at www.nhmrc.gov.au.

To organise an interview with Professor Geoffrey Lindeman or Associate Professor Sarah-Jane Dawson, please contact: Rachel Robertson, RocketComms 0419 881 791 or rachel@rocketcomms.com.au

Scientific Titles:

BRCA-P: An international randomised phase III study evaluating the RANK ligand inhibitor denosumab for the Prevention of breast cancer in BRCA1 mutation carriers

CAPTURE: Circulating tumour DNA Assessment of PIK3CA to guide Treatment REsponse