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 Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 9,358
- 主要终点
- Time to recurrence of breast cancer
研究概览
简要总结
The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven operable invasive breast cancer
- •Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
- •Women defined as post-menopausal
排除标准
- •Patients in whom there is any clinical evidence of metastatic disease
- •Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- •Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment
研究组 & 干预措施
2
Arimidex placebo + Nolvadex 20mg
干预措施: Anastozole (Arimidex) placebo (Drug)
1
Arimidex 1mg + Nolvadex placebo
干预措施: Anastozole (Arimidex) (Drug)
1
Arimidex 1mg + Nolvadex placebo
干预措施: Tamoxifen (Nolvadex) placebo (Drug)
2
Arimidex placebo + Nolvadex 20mg
干预措施: Tamoxifen (Nolvadex) (Drug)
3
Arimidex 1mg + Nolvadex 20mg
干预措施: Anastozole (Arimidex) (Drug)
3
Arimidex 1mg + Nolvadex 20mg
干预措施: Tamoxifen (Nolvadex) (Drug)
结局指标
主要结局
Time to recurrence of breast cancer
时间窗: Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
时间窗: Earliest of local or distant recurrence, new primary breast cancer, or death
次要结局
- Time to distant recurrence(Earliest of local or distant recurrence, new primary breast cancer, or death)
- Survival(Earliest of local or distant recurrence, new primary breast cancer, or death)
- New breast primaries(Earliest of local or distant recurrence, new primary breast cancer, or death)