NCT00944918已完成3 期
A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
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
- 25
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.
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 (Participant, Investigator)
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
- •Histologically or cytologically confirmed adenocarcinoma of the breast.
- •Metastatic disease must be measurable or evaluable
- •Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
- •NSAI given as adjuvant therapy that lasted ≥ 12 months OR
- •Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
- •Female postmenopausal patients
排除标准
- •Hormone receptor status
- •ER -ve and PgR NK
- •ER-ve and PgR -ve
- •Prescribed Tamoxifen for metastatic disease
- •Rapidly progressive visceral disease
- •Patients with malignancies within the last 5 years.
研究组 & 干预措施
1
Experimental
fulvestrant and anastrozole
干预措施: fulvestrant (Drug)
1
Experimental
fulvestrant and anastrozole
干预措施: anastrozole (Drug)
2
Experimental
fulvestrant and placebo
干预措施: fulvestrant (Drug)
3
Active Comparator
exemestane alone
干预措施: exemestane (Drug)
结局指标
主要结局
Progression-free survival
时间窗: every 3 months during treatment and, at time of discontinuation from treatment
次要结局
- Objective complete response (CR) and partial response (PR) rate(every 3 months during treatment and, at time of discontinuation from treatment)
- Duration of response(every 3 months during treatment and, at time of discontinuation from treatment)
- Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate(every 3 months during treatment and, at time of discontinuation from treatment)
研究者
研究点 (1)
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