Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9,779
- 试验地点
- 1
- 主要终点
- To compare recurrence free survival between two treatment groups.
研究概览
简要总结
To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)
This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081\&rank=1
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HR+ post-menopausal patients with non-metastatic breast cancer
排除标准
- •Any of the following: HR-, non-menopausal patient, metastatic breast cancer
研究组 & 干预措施
A
干预措施: exemestane (Drug)
B
干预措施: tamoxifen (Drug)
结局指标
主要结局
To compare recurrence free survival between two treatment groups.
时间窗: 2.75 years and 5 years
次要结局
- The quality of life of patients treated with exemestane to that of patients treated with tamoxifen(Every 3 months during first year then every 6 months for 4 years)
- Overall survival between the 2 treatment groups(Every 3 months during first year then every 6 months for 4 years)
- Incidence of a second breast cancer (contralateral) between the 2 treatment groups(Every 3 months during first year then every 6 months for 4 years)
- General tolerance in the short- and long-term between the 2 treatment groups(Every 3 months during first year then every 6 months dor 4 years)