NCT00784680已完成3 期
A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
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
- 308
- 主要终点
- Time to withdrawal
研究概览
简要总结
To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible for entry into the main ATAC trial 1033IL/0029
- •Completion of a baseline questionnaire
排除标准
- •Excluded from entry into the main ATAC trial (1033IL/0029)
- •If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons
研究组 & 干预措施
1
Active Comparator
Arimidex 1mg + Nolvadex placebo
干预措施: Anastrozole (Drug)
2
Active Comparator
Arimidex placebo + Nolvadex 20mg
干预措施: Anastrozole (Drug)
2
Active Comparator
Arimidex placebo + Nolvadex 20mg
干预措施: Tamoxifen (Drug)
3
Active Comparator
Arimidex 1mg + Nolvadex 20mg
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Time to withdrawal
Time to recurrence
次要结局
未报告次要终点
研究者
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未知
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