Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation (NCT04711109)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: USC / Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 25 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (47 Sites)
Showing the first 25 of 47 sites.
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- UCSF Medical Center-Mount Zion — San Francisco, California
- Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado
- UCHealth University of Colorado Hospital — Aurora, Colorado
- Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado
- Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado
- Rocky Mountain Cancer Centers-Midtown — Denver, Colorado
- Rocky Mountain Cancer Centers-Rose — Denver, Colorado
- Mountain Blue Cancer Care Center - Swedish — Englewood, Colorado
- Rocky Mountain Cancer Centers - Swedish — Englewood, Colorado
- Rocky Mountain Cancer Centers-Littleton — Littleton, Colorado
- Rocky Mountain Cancer Centers-Sky Ridge — Lone Tree, Colorado
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- Northwestern University — Chicago, Illinois
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois
- NorthShore University HealthSystem-Highland Park Hospital — Highland Park, Illinois
- Carle Cancer Center — Urbana, Illinois
- University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
- Maine Medical Center- Scarborough Campus — Scarborough, Maine
- Maine Medical Partners - South Portland — South Portland, Maine
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in BRCA1 Mutation
- BRCA Founder OutReach (BFOR) Study — Los Angeles, California
- BRCA1/2 Flu Vaccine — Philadelphia, Pennsylvania
- FaCT Trial (Facilitated Cascade Testing Trial) — New York, New York
- Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors — San Francisco, California
- An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results — Basking Ridge, New Jersey
Explore by condition: All BRCA1 Mutation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.