NCT02416427Unknown2 期
A Phase II, Randomized, Non-comparative, Pre-surgical Study of Atorvastatin or Observation in Ki-67 Positive, TAZ-expressing Early Breast Cancer Patients (TRINACRIA Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 78
- 主要终点
- Ki-67 reduction below the 15% (marker response).
研究概览
简要总结
This pre-surgical, window-of-opportunity study is designed to investigate whether atorvastatin reduces the proliferation marker Ki-67 via modulation of the Hippo transducer TAZ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Experimental
Atorvastatin 80 mg/day for 3 weeks
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Ki-67 reduction below the 15% (marker response).
时间窗: 4 weeks
次要结局
- • Decreased TAZ expression(4 weeks)
- Pathway inhibition(4 weeks)
研究者
Dr. Marcello Maugeri-Saccà
MD, PhD
Regina Elena Cancer Institute
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