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Denosumab for Breast Cancer Risk Reduction in Women With an Inherited BRCA1 Mutation (The Breast Cancer Prevention Study)

https://www.facingourrisk.org/research-clinical-trials/study/196/denosumab-for-breast-cancer-risk-reduction-in-women-with-an-inherited-brca1-mutation-the-breast-cancer-prevention-study

Clinicaltrials.gov identifier:
NCT04711109 (https://clinicaltrials.gov/show/NCT04711109)

Prevention
Prevention study enrolling women ages 25-55 with a BRCA1 mutation

Study Contact Information:

For additional information, please contact::
Judy E. Garber, MD, MPH: (617) 632-5961 or by email: [email protected]

About the Study

The BRCA-P Study is an international research study for women who are born with a mutation (change) in one of their BRCA1 genes. The main purpose is to find out if the study medication, denosumab, can decrease the risk of developing breast cancer compared to a placebo (inactive substance) in women with a BRCA1 gene mutation.

Denosumab is a drug approved by the FDA for treating osteoporosis (weakening of the bones) in healthy people. It is also approved for serious bone problems in people who have cancer that has metastasized (spread) to the bone. Some common side effects of denosumab include muscle and bone pain, shortness of breath, and low levels of calcium and phosphate in the blood. If you choose to take part in this study, your study doctor will carefully decide if denosumab is right for you.

Type of Study:

BRCA-P is a double-blind, randomized, two-arm study to evaluate the effects of denosumab on reducing breast cancer risk.

What the Study Involves

If you are eligible and decide to join the BRCA-P Study, you will be asked to:

You may also be asked to consider some optional studies (sub-studies). If you join a sub-study, you may be asked to:

Note: We highly recommend undergoing a dental exam before you join the study and taking calcium and vitamin D supplements while you are on the study. The study does not cover the costs of dental care and supplements. Please speak to your doctor if this presents a hardship to you.

Study Sites

California

Colorado

District of Columbia

Illinois

Kansas

Massachusetts

Maryland

Maine

Michigan

Minnesota

Nevada

New York

North Carolina

North Dakota

Ohio

Pennsylvania

South Carolina

Texas

Utah

Virginia

This Study is Open To:

You may be eligible to participate in the BRCA-P Study if you:

We encourage women of all racial and ethnic groups to participate in this study so that it fully represents all populations affected by BRCA1 mutations.

 

This Study is Not Open To:

The study is not open to people assigned at birth as male.

The study is not open to women:

 

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.