NCT00294996Unknown3 期
A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
Sopherion Therapeutics153 个研究点 分布在 5 个国家目标入组 363 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 363
- 试验地点
- 153
- 主要终点
- Progression-Free Survival
研究概览
简要总结
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.
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
- •Metastatic Her2+ Breast cancer by FISH analysis
- •No prior chemotherapy for metastatic disease
- •Measurable disease
- •normal left ventricular ejection fraction
排除标准
- •prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
- •relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
结局指标
主要结局
Progression-Free Survival
次要结局
- Overall Survival
- Safety
研究者
研究点 (153)
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