NCT00537771已完成4 期
A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Incidence of Fatty Liver Disease
研究概览
简要总结
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven HR+ invasive breast cancer
- •Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
- •Postmenopausal woman
排除标准
- •clinical evidence of metastatic disease
- •previous adjuvant hormonal therapy for breast cancer
- •liver diseases
研究组 & 干预措施
1
Experimental
Anastrozole (ARIMIDEX)
干预措施: Anastrozole (Drug)
2
Active Comparator
Tamoxifen
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Incidence of Fatty Liver Disease
时间窗: At 48 weeks, 96 weeks, 144 weeks
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
次要结局
- Incidence of Abnormal Liver Function(At 48 weeks, 96 weeks, 144 weeks)
- Time to Treatment Failure(Within 3 years)
研究者
研究点 (1)
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