EUCTR2016-001087-11-GB进行中（未招募）1 期
Chemoprevention in BRCA1 mutation carriers - a proof of concept study - CIBRAC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
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