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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 55
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5)

• Age >= 25 years and =< 55 years at randomization

• No evidence of breast cancer by MRI or mammography (MG) and clinical breast examination within the last 6 months prior to randomization

• No clinical evidence of ovarian cancer at randomization

• Negative pregnancy test at randomization for women of childbearing potential

• No preventive breast surgery planned at time of randomization

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Written informed consent before any study-specific procedure is performed

Locations
United States
Colorado
Rocky Mountain Cancer Centers-Aurora
Recruiting
Aurora
Rocky Mountain Cancer Centers-Boulder
Recruiting
Boulder
Rocky Mountain Cancer Centers - Centennial
Recruiting
Centennial
Rocky Mountain Cancer Centers-Midtown
Recruiting
Denver
Rocky Mountain Cancer Centers-Rose
Recruiting
Denver
Mountain Blue Cancer Care Center - Swedish
Recruiting
Englewood
Rocky Mountain Cancer Centers - Swedish
Recruiting
Englewood
Rocky Mountain Cancer Centers-Littleton
Suspended
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Recruiting
Lone Tree
Illinois
Carle Cancer Center
Recruiting
Urbana
Minnesota
Mayo Clinic in Rochester
Recruiting
Rochester
North Dakota
Sanford Roger Maris Cancer Center
Recruiting
Fargo
Texas
M D Anderson Cancer Center
Recruiting
Houston
Contact Information
Primary
Judy E. Garber, MD, MPH
judy_garber@dfci.harvard.edu
(617) 632-5961
Time Frame
Start Date: February 23, 2022
Estimated Completion Date: December 2033
Participants
Target number of participants: 300
Treatments
Experimental: Arm A (denosumab)
Patients receive denosumab SC q6m for up to 5 years in the absence of disease progression or unacceptable toxicity.
Placebo Comparator: Arm B (placebo)
Patients receive placebo SC q6m for up to 5 years in the absence of disease progression.
Related Therapeutic Areas
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: Austrian Breast & Colorectal Cancer Study Group (ABCSG), National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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