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Denosumab for Preventing Breast Cancer in Women with a BRCA1 Inherited Mutation (BRCA-P)

https://www.facingourrisk.org/research-clinical-trials/study/196/denosumab-for-preventing-breast-cancer-in-women-with-a-brca1-inherited-mutation-brca-p

Clinicaltrials.gov identifier:
NCT04711109 (https://clinicaltrials.gov/ct2/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

This is a study to test the effectiveness of a drug (denosumab) on preventing the development of breast cancer in women with an inherited BRCA1 mutation.

Denosumab is a drug that is currently used to treat bone loss in order to reduce the risk of broken bones in healthy people, and is also used 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 with an inherited BRCA1 mutation.

Type of Study:

This is a Phase 3, 2-arm, placebo-controlled, randomized study.

The study is randomized, which means participants will be assigned to one of the groups by chance. Neither the participants nor their doctors will know if they are taking the study drug or the placebo in this study.

What the Study Involves

Participants will be placed into one of the two study groups. All participants will receive an injection under the skin every 6 months for 5 years. Depending on which group they are placed in:

Participants will continue to receive recommended annual screening while in the study. After 5 years of treatment, participants will have yearly follow-up checks for 5 years.

The researchers will look at how many participants developed breast cancer and how participants tolerated the medication. 

Study Sites

Illinois

Minnesota

North Dakota

Texas


This Study is Open To:

Women age 25-55 with:

 

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.