NCT00171847终止4 期
An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Time to progression as assessed by clinical palpation and radiologic imaging every 3 months
研究概览
简要总结
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients
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
- •Her-2 overexpression and ER and/or PgR positive
- •Metastatic Breast Cancer
排除标准
- •Previous treatment with trastuzumab
- •Significant Liver or renal impairment
- •Erbb2 negative and/or ER and PgR negative
- •Other protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
A - HER-2 +ve patients with Femara alone
Experimental
干预措施: Letrozole (Drug)
B - HER-2 +ve patients with Femara + Herceptin
Experimental
干预措施: Trastuzumab plus Letrozole (Drug)
C - HER-2 -ve patients with Femara alone
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months
时间窗: 3 months
次要结局
- Duration of response/clinical benefit during treatment(3 months)
- Overall survival(3 months)
- Objective response rate/Clinical Benefit rate(3 months)
- Time to treatment failure(3 months)
研究者
研究点 (1)
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