ISRCTN15575894已完成2 期
A pilot prevention study of the effects of the anti-progestin Ulipristal acetate (UA) on surrogate markers of breast cancer risk
niversity Hospital of South Manchester0 个研究点目标入组 30 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Premenopausal females aged between 25 and 45 years
- •2. Regular menses defined as date of onset of last menstrual period +/ 3 days of expected
- •3. Known BRCA1 or BRCA2 mutation or moderate to high risk of developing BC defined as >17% lifetime risk from age 20 or >3% risk between 4050 years
- •4. Ovulatory menstrual cycles defined as serum progesterone =15nmol 7 days prior to expected onset of menses
- •5. eGFR = 40mls/min/1.73m2 in view of requirement for gadolinium contrast MRI scans
- •6. Willing and able to provide informed consent to undergo all trial procedures
排除标准
- •1. Personal history of breast, uterine, cervical or ovarian cancer
- •2. Breast feeding within the last 3 months
- •3. Pregnant or planning for pregnancy in the next 6 months. Pregnancy must be excluded with serum ßhCG <5nmol during screening.
- •4. Known hypersensitivity to radiological contrast media or to ulipristal acetate or any of its excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, talc, magnesium stearate)
- •5. Current treatment with:
- •5.1.Antiestrogens (e.g. tamoxifen or raloxifene), GnRH analogue therapy (e.g. goserelin or buserelin) or hormonal contraceptives including androgens such as cyproterone acetate. Such treatments must have been stopped for at least6 months and regular menstrual cycles resumed
- •5.2.Corticosteroids at any dose, these must have been stopped for at least 1 month with low likelihood that retreatment will be required
- •5.3.Antiplatelet or anticoagulant therapy – must have been stopped for at least 7 days and clotting be at satisfactory levels
- •5.4.Moderate or potent inhibitors of CYP3A4
- •5.5.Potent inducers of CYP3A4
- •6. APTT and PT outside the normal institutional ranges. Hb <100g/l and platelet count <150x109/l
- •7. Serum creatinine, bilirubin, ALT, ALP or LDH >1,5xULN
- •8. Contraindications to MRI, such as intracranial aneurysm clips, implanted electrical devices and intraocular metallic foreign bodies
- •9. Comorbidity that would put the patient at increased risk such as recognised bleeding diathesis, moderate to severe hepatic impairment, moderate or severe renal impairment (eGFR <40 ml/min/1.73m2), severe asthma not adequately controlled with corticosteroids (note steroid usage precludes trial entry)
- •10. Prior breast enhancement/augmentation surgery
- •11. Genital bleeding of unknown aetiology
研究者
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