NCT00065325已完成3 期
A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy
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
- 694
- 试验地点
- 1
- 主要终点
- Time to disease progression (TTP)
研究概览
简要总结
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
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
- 32 Years 至 91 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmation of Breast Cancer
- •Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
- •Postmenopausal women defined as a women who has stopped having menstrual periods
- •Evidence of hormone sensitivity
- •Written informed consent to participate in the trial
排除标准
- •Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
- •Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
- •Treatment with an investigational or non-approved drug within one month
- •An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
- •A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)
研究组 & 干预措施
1
Active Comparator
Exemestane
干预措施: Exemestane (Drug)
2
Experimental
Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Time to disease progression (TTP)
时间窗: after 580 Progression events accrued
次要结局
- Overall survival(after 580 Progression events accrued)
- Objective response rate(after 580 Progression events accrued)
- Duration of response(after 580 Progression events accrued)
- Clinical Benefit(after 580 Progression events accrued)
- Quality of Life(after 580 Progression events accrued)
- PK(each visit)
- Safety and tolerability.(after 580 Progression events accrued)
研究者
研究点 (1)
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