Clinical Trial

Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

Study acronym: BRCA-P
Active, Not Recruiting Phase 3
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Summary
This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2021-01-13; most recent amendment 2025-03-28.
Status change: Recruiting → Active, Not Recruiting 2025-01-14
Status change: Not Yet Recruiting → Recruiting 2022-05-19
Trial Details
NCT Number NCT04711109
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Austrian Breast & Colorectal Cancer Study Group
Conditions BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms, Breast Carcinoma, Neoplasms
Enrollment 300 participants
Start Date 2023-02-14
Primary Completion 2027-07 (estimated)
Study Completion 2033-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-02