Summary

Eligibility
for females ages 25-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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

Details

Keywords

BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms, Breast Carcinoma, Neoplasms, RANKL, Breast Cancer Prevention, Denosumab, Bone Density Conservation Agents, Physiological Effects of Drugs, Quality-of-Life Assessment

Eligibility

Locations

  • UCSF Medical Center-Mount Zion
    San Francisco California 94115 United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT04711109
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated