This research is to find out whether the study medication, denosumab, can help prevent breast cancer in women with a BRCA1 mutation.
About this study
The research also aims to find out whether denosumab decreases the risk of developing ovarian cancer or other types of cancer, study the safety of using denosumab, and study its effect on bone health.
The study is a randomised, double-blind, placebo-controlled study. This means that participants will receive an injection of either denosumab or placebo every 6 months for 5 years.
Study duration: 10 years
Participants will need to visit their study doctor every 6 months while receiving the medication, then continue to be checked by their study team every 12 months for a further 5 years.
Anticipated enrolment close date: Ongoing
Contact the Breast Trials Team for more information.
Who can take part
- Women with the BRCA1 mutation
- Aged between 25 and 55 years
- No evidence of breast or ovarian cancer
- No preventive breast surgery (mastectomy) planned
- People with a history of breast or ovarian cancer
- People with both breasts removed (double mastectomy)
- Pregnant or lactating women
- Breast MRI
- Bone density scan
- Blood tests at each visit
- Quality of life questionnaires at various intervals
- Injection of either denosumab or the placebo every 6 months for 5 years
- Follow-up visits once every 12 months for 5 years
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.