A Study of Denosumab to Prevent Breast Cancer in Women With an Inherited BRCA1 Mutation

Full 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 (A211801) (CIRB)

Purpose

Researchers want to see if denosumab reduces the risk of breast cancer in women with an inherited BRCA1 mutation. This mutation raises the risk of breast and other cancers.

Denosumab is used to treat bone loss and reduce the risk of bone fractures. It is also used to reduce new bone growths in people with bone metastases (cancer that has spread to the bones).

If you join this study, you will be randomly assigned to get either denosumab or a placebo (inactive drug). Each is given as an injection under the skin for up to 5 years.

Who Can Join

To join this study, there are a few conditions. You must:

• Be a woman (assigned female at birth) with an inherited BRCA1 mutation.
• Have never been diagnosed with breast or ovarian cancer.
• Have never received denosumab.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 25-55.

Contact

For more information and to see if you can join this study, please contact Dr. Mark Robson’s office at 646-888-5486.