An Australian-led international trial to investigate whether a common osteoporosis drug can delay or prevent breast cancer in women with an inherited BRCA1 mutation is actively recruiting.
Previously published laboratory research by the co-principal investigator of the Breast Cancer Trials BRCA-P trial, Professor Geoff Lindeman, suggested RANKL blockade was a promising strategy in the prevention of breast cancer.
Because of these promising results, the trial, which will determine if switching off RANK ligand with denosumab delays or prevents breast cancer in high-risk women, has been fast-tracked.
According to Professor Lindeman, a medical oncologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, the results of the trial could potentially herald a landmark breakthrough for women with the genetic mutation who typically have a 70% risk of developing breast cancer over the course of their lifetime and a 40% risk of developing ovarian cancer.
Across Australia over the next two years, 14 sites will aim to recruit 300 women with the BRCA1 gene mutation, who are aged 25 to 55 years and breast and ovarian cancer-free. Austria, Germany, Israel, Spain, the UK and the US are also recruiting patients to the trial.
Denosumab is approved in Australia for the treatment of osteoporosis in postmenopausal people and for the prevention of bone-related problems in adults with bone metastases due to cancer.