NCT01654185已完成2 期
Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.
Xichun Hu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.
详细描述
The addition of dimethyldiguanide might increase the efficacy of AI in patients with metastatic breast cancer after the failure of the first line endocrine therapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal HR positive breast cancer patients;
- •inoperable locally advanced or metastatic breast cancer patients;
- •candidate for endocrine therapy;
- •ECOG equal to or less than 1;
- •adequate bone marrow function(Hb>=90g/L, WBC >=3.5×10^9/L,ANC>=1.5×10^9/L, PLT>=80×10^9/L; adequate renal function(Ccr<=ULN);adequate liver function(ALT,AST,AKP<=2.5*ULN,or <=5*ULN if liver metastases)
- •life expectancy >=12weeks;
- •no severe history disease of liver,heart,lung or kidney;
- •written informed consent form;
排除标准
- •Her-2 overexpression;
- •patients who has visceral endocrisis；
研究组 & 干预措施
AI plus Dimethyldiguanide
Experimental
AI 1 tablet qd plus Dimethyldiguanide 0.5 bid
干预措施: AI plus Dimethyldiguanide (Drug)
Aromatase Inhibitor
Active Comparator
AI monotherapy
干预措施: Aromatase Inhibitor (Drug)
结局指标
主要结局
progression free survival
时间窗: 9 months
次要结局
未报告次要终点
研究者
Xichun Hu
Deputy director of department of medical oncology
Fudan University
研究点 (1)
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