Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,172
- 试验地点
- 41
- 主要终点
- Disease Free Survival
研究概览
简要总结
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
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
- 33 Years 至 96 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Recent primary surgery for breast cancer
- •Early stage breast cancer
- •Postmenopausal
- •Hormone receptor positive
- •Positive lymph node involvement
排除标准
- •Metastatic disease
- •Presence of contralateral breast cancer including DCIS
- •Progression
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Letrozole
2.5 mg by mouth (p.o.) once daily
干预措施: Letrozole (Drug)
Anastrozole
1 mg p.o. once daily
干预措施: Anastrozole (Drug)
结局指标
主要结局
Disease Free Survival
时间窗: 84 months
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
次要结局
- Distant Disease-free Survival(84 months)
- Percentage of Participants Who Experienced Clinical Fracture Events(84 months)
- Time to Development of Distant Metastases(84 months)
- Overall Survival(84 months)
- Time to Development of Contra Lateral Breast Cancer(84 months)
- Percentage of Participants Who Experienced Cardiovascular Events(84 months)
- Change From Baseline in Serum Lipid Profiles(baseline, 6, 12, 24, 36, 48 and 60 months)