NCT00784940已完成3 期
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) 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 assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.
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
- •Women defined as post-menopausal
- •Patients with histologically proven operable invasive breast cancer
- •Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated
排除标准
- •Excluded from entry into the main ATAC trial (1033IL/0029)
- •Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
- •Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
- •Patients who have had a bone fracture within the previous 6 months prior to randomisation
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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