MedTrace Logo

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

NCT04711109 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-04-02

No results posted yet for this 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.

Conditions

  • BRCA1 Mutation
  • Breast Cancer
  • Breast Diseases
  • Breast Neoplasms
  • Breast Carcinoma
  • Neoplasms

Interventions

DRUG

Denosumab

Given SC

DRUG

Placebo

Given SC

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Austrian Breast & Colorectal Cancer Study Group (ABCSG)

    collaborator UNKNOWN

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Judy E. Garber, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2027-07-31
Completion
2033-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711109 on ClinicalTrials.gov