NCT00357110已完成2 期
A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow
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
- 13
- 试验地点
- 2
- 主要终点
- Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
研究概览
简要总结
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation
排除标准
- •Inflammatory and/or metastatic breast cancer.
- •Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
- •History of bleeding diathesis.
研究组 & 干预措施
2
Experimental
Anastrozole + Fulvestrant
干预措施: Anastrozole (Drug)
1
Active Comparator
Anastrozole monotherapy
干预措施: Anastrozole (Drug)
2
Experimental
Anastrozole + Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
时间窗: 12 month period following randomisation
Number of patients event-free
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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A randomised Phase II Study comparing anastrozole and fulvestrant to an-astrozole for adjuvant treatment of postmenopausal patients with early breast cancer and disseminated tumour cells in bone marrow - ABCSG 21postmenopausal women with hormone receptor positive early breast cancerEUCTR2005-005715-22-ATAstraZeneca AB176
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