Table 5

Trial registration data

Data categoryInformation
Primary registry and trial registration numberEudraCT: 2016-001087-11
Date of registration in primary registry9 March 2016
Sources of monetary or material supportSupported by a Cancer Research UK Clinical Research Training Fellowship
SponsorBelfast Health and Social Care Trust
Contact for public queriesAMC (
Contact for scientific queriesSAM  (, KIS (
Public titleCIBRAC: chemoprevention in BRCA1 mutation carriers
Scientific titleChemoprevention in BRCA1 mutation carriers (CIBRAC): an open allocation crossover trial assessing mechanisms of chemoprevention of goserelin and anastrozole versus tamoxifen
Countries of recruitmentUK (Northern Ireland)
InterventionsTamoxifen 20 mg daily (oral), goserelin 3.6 mg every 28 days (subcutaneously) plus anastrozole 1 mg daily (oral)
Key inclusion criteriaAges eligible for study ≥18 years.
Sex eligible for study: female.
Known pathogenic germline BRCA1 mutation.
No previous breast or ovarian risk-reducing surgery.
Key exclusion criteriaPersonal history of breast or ovarian carcinoma.
Previous risk-reducing breast or ovarian surgery.
Postmenopausal status.
Study typeInterventional.
Allocation: alternate treatment allocation, non-randomised, non-blinded.
Primary purpose: prevention.
Phase II.
Date of first enrolmentMay 2017
Recruitment statusRecruiting
Primary outcomeEstablish the acceptability of trial treatments as a chemopreventive strategy in BRCA1 mutation carriers, as measured by the number of patients entering the trial and compliance with treatment.
Key secondary outcomesTo establish tolerability of trial treatments and procedures.