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ACTIVE NOT RECRUITING Phase 3

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

NCT04711109 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 300 participants
Start Date 2023-02-14
Est. Completion 2033-12
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04711109

The ClinicalTrials.gov registry entry for NCT04711109 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04711109 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Colorado, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04711109?

The interventions under investigation include: Placebo (DRUG), Quality-of-Life Assessment (OTHER), Denosumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04711109?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial