NCT01589159已完成2 期
A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes
Tao OUYANG1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年1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
- 54
- 试验地点
- 1
- 主要终点
- Clinical benefit rate
研究概览
简要总结
This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients between 18 and 65 years old
- •patients with metastatic breast cancer previousely treated with A/T
- •able and willing to give consent to participate in the study
排除标准
- •pregnant or lactating females
- •other tumor history
- •instable complication (e.g., myocardial infarction within 6 months,arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
- •concurrent disease or condition that would make the patient inappropriate for study participation
- •resist to participate in the study
研究组 & 干预措施
Experimental
Experimental
干预措施: Capecitabine (Drug)
Experimental
Experimental
干预措施: Etoposide (Drug)
结局指标
主要结局
Clinical benefit rate
时间窗: 24 weeks after the treatment
Clinical benefit is defined as CR, PR, SD≥24 weeks.
次要结局
未报告次要终点
研究者
Tao OUYANG
Chairman of Breast Center
Peking University
研究点 (1)
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