NCT00099281终止3 期
A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in Metastatic/Recurrent Breast Cancer
YM BioSciences1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic and/or recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment. Stratification allocation will be within the following subgroups:
- Prior cytotoxic treatment;
- Estrogen receptor status;
- ECOG performance status;
- Number of cycles of chemotherapy.
详细描述
Endpoints of the trial are as follows:
primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological proof of breast cancer
- •Documented evidence of metastatic and/or recurrent breast cancer
- •Presence of at least one bi-dimensional or uni-dimensional lesion
- •ECOG status 0, 1 or 2
- •Quality of life
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Neurocognitive function
- Toxicity
- Response rate
- Progression-free survival
研究者
研究点 (1)
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