drugset / Trial / NCT04711109
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
Phase 3
Active not recruiting
300 enrolled
Alliance for Clinical Trials in Oncology
Austrian Breast & Colorectal Cancer Study Group · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
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.
Timeline
- Start
- 2023-02-14
- Primary completion
- 2027-07
- Completion
- 2033-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | — | Subcutaneous |