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NCT04711109 · ClinicalTrials.gov registry record · Phase 3
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
A Phase 3 study of Breast Cancer and Neoplasms, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT04711109: Active Phase 3 study of Breast Cancer and Neoplasms, sponsored by Alliance for Clinical Trials in Oncology.
NCT04711109 is a Phase 3 study of Breast Cancer and Neoplasms that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 300 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04711109, a Phase 3 study of Breast Cancer and Neoplasms, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Time to breast cancer (invasive or DCIS) will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Quality-of-Life Assessment
- DRUG Denosumab
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- UCHealth University of Colorado Hospital - Aurora
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Rocky Mountain Cancer Centers - Centennial - Centennial
- Rocky Mountain Cancer Centers-Midtown - Denver
- Rocky Mountain Cancer Centers-Rose - Denver
- Mountain Blue Cancer Care Center - Swedish - Englewood
- Rocky Mountain Cancer Centers - Swedish - Englewood
- Rocky Mountain Cancer Centers-Littleton - Littleton
- Rocky Mountain Cancer Centers-Sky Ridge - Lone Tree
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
- NorthShore University HealthSystem-Highland Park Hospital - Highland Park
- Carle Cancer Center - Urbana
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UCSF Medical Center-Mount Zion - San Francisco
Kansas
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2033-12 |
| Phase | Phase 3 |
What the registry record for NCT04711109 still lists
NCT04711109 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04711109 names 20 study sites across 5 states, led by Colorado, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT04711109 about?
NCT04711109 is a clinical study titled "Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation". 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 antibo...
What is the current status of trial NCT04711109?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2023-02-14. Estimated completion is 2033-12.
What conditions does trial NCT04711109 study?
This clinical trial studies the following conditions: Breast Cancer, Neoplasms, Breast Carcinoma, Breast Neoplasms, BRCA1 Mutation.
What interventions are being tested in trial NCT04711109?
The interventions under investigation include: Placebo (DRUG), Quality-of-Life Assessment (OTHER), Denosumab (DRUG).
Who is sponsoring clinical trial NCT04711109?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04711109 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04711109's enrollment target sits among peer trials
300 277th of 1224 higher than 938 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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