NCT00814125已完成3 期
A Randomised, Double Blind Trial to Assess the Incidence of Endometrial Changes 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
- 285
- 主要终点
- Withdrawl
研究概览
简要总结
To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.
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
- •Patients eligible for entry into the main ATAC trial (1033IL/0029)
- •Not received any previous tamoxifen, for whatever reason
- •Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years
- •No previous endometrial ablation
排除标准
- •Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)
研究组 & 干预措施
1
Active Comparator
Arimidex 1mg + Nolvadex placebo
干预措施: Anastrozole (Arimidex) (Drug)
1
Active Comparator
Arimidex 1mg + Nolvadex placebo
干预措施: Nolvadex placebo (Drug)
2
Active Comparator
Arimidex placebo + Nolvadex 20mg
干预措施: Tamoxifen (Nolvadex) (Drug)
2
Active Comparator
Arimidex placebo + Nolvadex 20mg
干预措施: Arimidex placebo (Drug)
3
Active Comparator
Arimidex 1mg + Nolvadex 20mg
干预措施: Anastrozole (Arimidex) (Drug)
3
Active Comparator
Arimidex 1mg + Nolvadex 20mg
干预措施: Tamoxifen (Nolvadex) (Drug)
结局指标
主要结局
Withdrawl
Death
次要结局
未报告次要终点
研究者
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不适用
A randomised double-blind trial comparing arimidex alone with nolvadex alone with arimidex and nolvadex in combination, as adjuvant treatment in post-menopausal women with breast cancerCancerBreast cancerISRCTN18233230AstraZeneca Clinical Research Group (UK)