Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
Public ClinicalTrials.gov record NCT04711109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04711109
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 300 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 25 Years to 55 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2023 (Actual)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Dec 2033 (Estimated)
- Last update posted
- Oct 5, 2026
2023 – 2033
United States locations
- U.S. sites
- 47
- U.S. states
- 20
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | — |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | — |
| Rocky Mountain Cancer Centers - Centennial | Centennial | Colorado | 80112 | — |
| Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers-Rose | Denver | Colorado | 80220 | — |
| Mountain Blue Cancer Care Center - Swedish | Englewood | Colorado | 80113 | — |
| Rocky Mountain Cancer Centers - Swedish | Englewood | Colorado | 80113 | — |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | — |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| Maine Medical Center- Scarborough Campus | Scarborough | Maine | 04074 | — |
| Maine Medical Partners - South Portland | South Portland | Maine | 04106 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89148 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Novant Health Breast Surgery - Greensboro | Greensboro | North Carolina | 27403 | — |
| Novant Health Cancer Institute - Kernersville | Kernersville | North Carolina | 27284 | — |
| Novant Health Cancer Institute - Mount Airy | Mount Airy | North Carolina | 27030 | — |
| Novant Health Cancer Institute - Thomasville | Thomasville | North Carolina | 27360 | — |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04711109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04711109 live on ClinicalTrials.gov.