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Trial 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.

Acronym:

BRACAp

ACTRN/NCT /ethics:

NCT04711109

Scientific title:

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

Sponsor / Cooperative group:

Alliance for Clinical Trials in Oncology

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase III
Age Range25 to 55 years
SexFemale
Tumour Stream -
Cancer Stage-
Anticipated Start Date2022-02-23
Anticipated End Date2033-12-01

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
EmailAnne.Milton@sa.gv.au
Phone08 7074 2342
Principal InvestigatorEryn Dow
Recruitment StatusRecruiting