NCT00635713已完成3 期
A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 588
- 主要终点
- time to tumor progression
研究概览
简要总结
The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced 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
- Double
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 women with confirmation of breast cancer
- •objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer
排除标准
- •presence of life-threatening metastatic visceral disease
- •previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
- •more than 1 prior endocrine medical treatment for advanced breast cancer .
研究组 & 干预措施
1
Experimental
Faslodex 125mg and Arimidex 1 mg
干预措施: Fulvestrant (Drug)
1
Experimental
Faslodex 125mg and Arimidex 1 mg
干预措施: Anastrozole (Drug)
2
Experimental
Faslodex 250mg and Arimidex 1mg
干预措施: Anastrozole (Drug)
2
Experimental
Faslodex 250mg and Arimidex 1mg
干预措施: Fulvestrant (Drug)
结局指标
主要结局
time to tumor progression
时间窗: Every 3 months
次要结局
- time to treatment failure(Every 3 months)
- time to death(Every 3 months)
- objective tumor response(Every 3 months)
研究者
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