Major Program
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Alliance for Clinical Trials in Oncology
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT04711109
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, Kendrith M. Rowland, Sandhya Pruthi, Isabelle Bedrosian, Darcy V. Spicer, Marie E. Wood, Claudine Isaacs, Seema A. Khan, Katharine A. Yao, Lauren Nye, Judy E. Garber, John A. Ellerton, Katherine D. Crew, Judith O. Hopkins, Susan M. Domchek, Phuong L. Mai, Sarah V. Colonna, Masey M. Ross, Site Public Contact, Sagar D. Sardesai, Lori F. Gentile, Kathleen J. Yost, Rachel D. Wooldridge, Melissa L. Pilewskie, Kara K. Landry, Mark E. Robson, Susan Miesfeldt, Olufunmilayo F. Olopade, Kala Visvanathan, Pamela N. Munster, Nicholas J. DiBella