EUCTR2008-005863-32-SE进行中（未招募）不适用
A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer - a Window-of Opportunity Study - MAST
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Women with primary breast cancer who are candidates for radical surgery.
- •Breast tumours clinically = 15 mm, Nx, M0.
- •Breast tumours identified on mammography and verified on fine needle aspiration.
- •Age > 18 years.
- •Postmenopausal women. Postmenopausal status defined as = 1 year since last menstruation in women with no medical history of hysterectomy or women with a medical history of oophofectomy.
- •Performance status of ECOG = 1.
- •Laboratory requirements at the day of diagnosis (t1-): Prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
- •Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
- •prior breast cancer treatment.
- •current HRT.
- •known liver disease.
- •history of hemorrhagic stroke.
- •psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
- •history of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
研究者
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