A trial to investigate the effects of denosumab on normal breast tissue in patients with BRCA 1 or 2 mutations and to determine if the drug has the potential to prevent breast cancer.
About this study
Denosumab is approved for use in osteoporosis. Laboratory research has identified other potential effects, including possibly slowing or stopping breast cell growth.
Breast tissue will be obtained and evaluated before and after the denosumab injections.
Note that this is a pilot drug study and does not fall under the phase I to IV categories.
Anticipated enrolment close date: Ongoing
Who can take part
- People with documented BRCA1 or BRCA2 mutation
- Normal blood calcium levels
What's involved
- Breast MRI and breast biopsy
- Three to five clinic visits for physical examination and blood tests
- Injection of denosumab every 28 days
- Participants must agree to take calcium and vitamin D supplementation
- Participants with reproductive potential must be willing to use acceptable methods of effective contraception (with the exception of hormonal contraception)
Links & documents
Ethics
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.