CIBRAC - Chemoprevention in BRCA1 mutation carriers
- Conditions
- BRCA1 mutation carrier Breast CancerMedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10064117Term: Familial risk factorSystem Organ Class: 10041244 - Social circumstancesTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001087-11-GB
- Lead Sponsor
- Belfast Health and Social Care Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
1.Age >18 years
2.Premenopausal
3.Known pathogenic BRCA1 mutation
4.Intact ovaries
5.No previous breast/ovarian carcinoma
6.No other previous malignancy
7.No previous use of chemoprevention
8. Willingness to use contraception
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
1.BRCA1 mutation of uncertain significance
2.Personal history of breast or ovarian carcinoma
3.Previous risk-reducing breast or ovarian surgery
4.Post-menopausal status
5.Concomitant use of alternative chemoprevention regimens
6.Concomitant use of other hormonal agents (within one month of trial enrolment)
7.Contraindications to study drug therapies
8.Contraindications to breast core biopsies
9.Pregnancy or breastfeeding
10.Inability to give informed consent
11.Having made a decision to proceed with risk reducing surgery and on surgical waiting list.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method