NCT01061359已完成不适用
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer ((ANWENDUNGSBEOBACHTUNG,MOI 99056 -Neo-/Adjuvante Chemotherapie Des Primären Mammakarzinoms Der Frau Mit Farmorubicin®))
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,981
- 主要终点
- Percentage of Participants With Disease Free Survival (DFS)
研究概览
简要总结
Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) / C(600mg). Evaluation of unexpected and serious adverse events.
(E=Epirubicin; C =Cyclophosphamide)
详细描述
Postmarketing surveillance study. Non-Probability Sample
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre- and postmenopausal female patients with histologically confirmed primary breast cancer
排除标准
- •Metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer history
结局指标
主要结局
Percentage of Participants With Disease Free Survival (DFS)
时间窗: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Percentage of participants with DFS who completed 5 year follow-up visit.
次要结局
- Time to Progression (TTP)(3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y)
- Time to Recurrence (DFI)(3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y)
研究者
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