NCT00287534已完成2 期
A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,059
- 试验地点
- 1
- 主要终点
- To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
研究概览
简要总结
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early 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
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Post-menopausal women ≤75 years,
- •histologically confirmed invasive breast carcinoma (no distant metastases),
- •positive hormone receptor status,
- •continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery
排除标准
- •menopause status maintained by medication,
- •pre-operative chemotherapy or hormone therapy or radiation therapy,
- •relapse or second carcinoma or previous cancerous disease,
- •breast carcinoma in situ,
- •simultaneous carcinoma of the opposite side or secondary breast,
- •10 or more tumour-infiltrated lymph nodes.
- •serious accompanying diseases
研究组 & 干预措施
1
Experimental
Anastrozole
干预措施: Anastrozole (Drug)
2
Active Comparator
Tamoxifen
干预措施: Tamoxifen (Drug)
结局指标
主要结局
To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen
次要结局
- To assess difference in overall survival between the two treatment arms
- To assess difference in disease recurrence between the two treatment arms
- To assess difference in safety and tolerability between the two treatment arms
研究者
研究点 (1)
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