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

Breaking it down:

Is there a non-surgical way to reduce breast cancer risk in women with a BRCA1 mutation?

Eligibility Criteria:

1. Women who have a confirmed BRCA1 gene mutation (variant)
2. 25 to 55 years of age
3. Do NOT have a history of breast or ovarian cancer
4. Not pregnant or breastfeeding
5. Have not had a mastectomy

Treatments:

• Subcutaneous (SQ) injection under the skin of denosumab or
• Placebo once every 6 months for 5 years

Drugs used:

• Denosumab is a well-tolerated drug approved by the FDA to treat osteoporosis in healthy people and in cancer patients whose cancer has spread to their bones. Side effects include muscle and bone pain, shortness of breath, and low levels of calcium and phosphate in the blood.

Locations and Contacts:

30 locations through-out the United States, include Pittsburgh.

• Carol Glock M.Ed
  Phone: 412-680-6496
• Cortney Montgomery BSN, RN, CCRP, CBCN
  Phone: 412-641-1840