NCT00272740已完成2 期
An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 93
- 试验地点
- 9
- 主要终点
- Clinical Benefit Rate
研究概览
简要总结
The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological/cytological confirmation of breast cancer
- •progression under treatment with an aromatase inhibitor
- •At least one measurable or non-measurable lesion
排除标准
- •Prior treatment for breast cancer with more than 2 different hormonal agents
- •More than 1 chemotherapy for advanced disease
- •Presence of life-threatening metastatic visceral disease
结局指标
主要结局
Clinical Benefit Rate
次要结局
- Time to progression
- Duration of clinical benefit
- Duration of response
- Time to treatment failure
- Safety and tolerability
- 6. clinical benefit rate according to HER2/neu status
研究者
研究点 (9)
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