NCT00524810已完成2 期
A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer
ARCAGY/ GINECO GROUP1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2004年2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
- 67
- 试验地点
- 1
- 主要终点
- Non-progression rate after 6 cycles
研究概览
简要总结
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer
详细描述
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first metastatic chemo line
- •presence of measurable or bone lesion
- •at least one lesion outside the radiated areas
- •can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks
排除标准
- •only local tumoral progression
- •symptomatic cerebral metastasis
- •neuropathy > NCI-CTC 2
- •previous cancer within 10 years _ previous cancer within 10 years
研究组 & 干预措施
Caelyx - Taxotere
Experimental
干预措施: Pegylated liposomal doxorubicin (Drug)
Caelyx - Taxotere
Experimental
干预措施: Docetaxel (Drug)
结局指标
主要结局
Non-progression rate after 6 cycles
时间窗: 6 months
次要结局
- tolerance and toxicity(6 months)
- Time to Progression(5 years)
- Tumor response and duration(5 years)
- Overall survival(5 years)
研究者
研究点 (1)
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