BRCA-P clinical trial is the first clinical trial in prevention of breast cancer, which was launched in April 2020. So far, we have three active participants on this trial and a few potential patients have expressed their interest to participate.
The BRCA-P study is looking at a new cancer prevention option involving a study medication injection (Denosumab or placebo) every six months for five years. In addition, participants will have a visit with their study doctor every six months, and will have their bone health and quality of life assessed every 12 months while receiving the study medication. These assessments are not typically part of standard medical care for women carrying a BRCA1 mutation. Participants will also continue to be checked by their study team every 12 months for a further five years (total of 10 years).
Denosumab is approved in Australia for the treatment of osteoporosis (60mg, Prolia®) and for the prevention of bone-related problems in adults with bone metastases from cancers (120 mg, XGEVA®). It has not been approved as a prevention medication for people with a mutation in the BRCA1 gene. Its use in this study is experimental.
Eligibility:
- Women with a confirmed BRCA1 gene mutation
- Aged 25-55 years, no evidence of breast cancer clinically and imaging (MRI, mammogram)
- No history of mastectomy
- No history of ovarian cancer
