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

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 has 2 arms. Participants will be placed into one of two groups.
  • Group 1 will be given the study drug, denosumab
  • Group 2 will be given a placebo

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:

• people in group 1 will receive an injection of the study drug denosumab      
• people in group 2 will receive a placebo injection    

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

• Urbana, IL
  Carle Cancer Center
  Contact: 800-446-5532 or by email at: [email protected]       
  Lead Researcher:  Kendrith M. Rowland         

Minnesota

• Rochester, MN
  Mayo Clinic in Rochester
• Contact: Site Public Contact 855-776-0015      
  Lead Researcher: Sandhya Pruthi         

North Dakota

• Fargo, ND
  Sanford Roger Maris Cancer Center
  Contact: Site Public Contact: 701-234-6161 or by email at: [email protected]    
  Lead Researcher: Preston D. Steen         

Texas

• Houston, TX
  M D Anderson Cancer Center
  Contact: Site Public Contact: 877-632-6789 or by email at: [email protected]
  Lead Researcher: Isabelle Bedrosian         

Women age 25-55 with:

• Confirmed inherited mutation in BRCA 1.
• No risk-reducing breast surgery planned at time of study.
• No evidence of breast cancer by MRI or mammography (MG) and breast examination within 6 months of joining study.    

 

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

The study is not open to women:

• who have had a prior bilateral mastectomy.
• who have a history of breast or ovarian cancer (including fallopian and peritoneal cancer).    
• who use any of the following medications: 
  • denosumab.
  • tamoxifen, raloxifene or aromatase inhibitor during the last 3 months prior to joining the study, or for a duration of more than 3 years in total.
  • Current treatment with a bisphosphonate or an anti-angiogenic agent.
• who have an active infection with hepatitis B virus or hepatitis C virus.
• who have human immunodeficiency virus (HIV).
• who have a diagnosis of dental or jaw condition such as osteonecrosis or osteomyelitis, or a condition that requires oral. surgery within 3 months of joining the study.