NCT00332852已完成3 期
An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 655
- 试验地点
- 3
- 主要终点
- Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging
研究概览
简要总结
This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.
This trial is not recruiting patients in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Letrozole
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging
时间窗: after 24 months
次要结局
- Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months(Every 6 months)
- Disease free survival (DFS)(every 6 months for 24 months)
- Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation(every 6 months)
研究者
研究点 (3)
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