NCT00327769已完成3 期
A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive 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
- 234
- 试验地点
- 1
- 主要终点
- Time to Disease Progression (TTP)
研究概览
简要总结
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 advanced breast cancer with oestrogen receptor positive
- •Progression under first-line anti-oestrogen therapy.
排除标准
- •Life-threatening metastasis; contraindication to anastrozole
- •>2 regimens of hormonotherapy for advanced breast cancer
研究组 & 干预措施
2
Experimental
Anastrozole + Fulvestrant
干预措施: Anastrozole (Drug)
1
Active Comparator
Anastrozole
干预措施: Anastrozole (Drug)
2
Experimental
Anastrozole + Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Time to Disease Progression (TTP)
次要结局
- Safety & Tolerability.
- Clinical Benefit Rate (CBR)
- Objective Response Rate (ORR)
- Time to Treatment Failure (TTF)
研究者
研究点 (1)
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