NCT00816244已完成2 期
A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer: A Window-of-Opportunity Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tumor biological alterations following two weeks of neo-adjuvant statin therapy in postmenopausal breast cancer patients; to evaluate the tumor proliferation using Ki67 as proliferation marker.
研究概览
简要总结
The purpose of this study is to monitor:
- Tumor biological alterations following two weeks of neo-adjuvant statin therapy.
- Effects of statins on tumor proliferation.
- Functional studies on the mevalonate pathway.
详细描述
Blood samples and three core biopsies are taken after diagnosis. Treatment with atorvastatin at a daily dosis of 80 mg is initiated 14 days before planned surgery. Translational research will be performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with primary breast cancer who are candidates for radical surgery.
- •Breast tumours clinically ≥ 15 mm, Nx, M
- •Breast tumours identified on mammography and verified on fine needle aspiration.
- •Age > 18 years.
- •Performance status of ECOG ≤
- •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.
- •Negative pregnancy test for pre menopausal women before inclusion in the trial
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.
研究组 & 干预措施
Atorvastatin
Experimental
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Tumor biological alterations following two weeks of neo-adjuvant statin therapy in postmenopausal breast cancer patients; to evaluate the tumor proliferation using Ki67 as proliferation marker.
时间窗: After two weeks of treatment with statin therapy.
次要结局
- Assessments of apoptosis using immunohistochemistry.(After two weeks of treatment with statin therapy.)
研究者
研究点 (1)
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