BRCA-P
Research type
Research Study
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
IRAS ID
1005699
Contact name
Gareth Evans
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2017-002505-35
ISRCTN Number
ISRCTN77394655
Clinicaltrials.gov Identifier
Research summary
This is an international, multi-center, phase III, double-blinded, placebo-controlled, prospective, randomized
interventional prevention trial.
The primary aim of the study is to establish if there is a reduction in the risk of any breast cancer (invasive or DCIS) in
women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
The study duration is projected to be a total of 12 years, comprising of a 2 year enrolment phase, a 5 year treatment
phase and 5 year follow up phase.
The target recruitment is 2918 participants. Once consented, participants will be randomised in a 1:1 ratio using
interactive voice and/or web-based response system (IxRS).
Arm A will be treated with: Denosumab 120 mg s.c., q6m for a duration of 5 years. Arm B will be treated with:Arm B
(Placebo Comparator): Placebo s.c., q6m for a duration of 5 years.
The participants participation in the study will involve a screening/consent visit followed by treatment visits every 6
months for a duration of 5 years. Participants will then be follow-ed up every 12 months for 5 years after the point that
the last investigation product is administered.REC name
Wales REC 5
REC reference
22/WA/0204
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion