BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation

The purpose of this study is to find out whether denosumab can decrease or prevent the risk of developing breast cancer in women carrying the BRCA1 mutation, looking at whether denosumab can decrease the risk of developing ovarian cancer or other types of cancer in women carrying the BRCA1 mutation, and studying the drug’s safety and its effect on bone health. The study team also will be monitoring for any potential side effects the drug might cause.

Are you Eligible? (Inclusion Criteria)

• Are you between the ages of 25 and 55?
• Have doctors found that you have a mutation in the BRCA1 gene and you have never
• had breast or ovarian cancer?
• Are you able to come to the clinic for study visits every 6 months?