Trial NCT04711109

Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

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.

Intervention

Denosumab, Placebo, Quality-of-Life Assessment

Condition

BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms, Breast Carcinoma, Neoplasms

Investigators

Judy E. Garber, MD, MPH, Nicholas DiBella, Kendrith M. Rowland, Sandhya Pruthi, Preston D. Steen, Isabelle Bedrosian

See list of participating sites