ISRCTN38983527已完成不适用
Phase I/II single-arm interventional pilot study of capecitabine with or without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer
AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany)0 个研究点目标入组 50 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Aged 18 to 65 years, female
- •2. Histologically confirmed stage II/IIIA breast cancer with four or more positive axillary lymph nodes
- •3. Had undergone surgery (complete surgical resection [R0] of breast tumour and axilla) before inclusion in the study
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •5. Left ventricular ejection fraction within the normal institutional range
- •6. Adequate haematological, renal and hepatic function
- •7. Provided written informed consent
排除标准
- •1. Inflammatory breast cancer
- •2. Received neoadjuvant endocrine therapy, chemotherapy or radiotherapy
- •3. Known dihydropyrimidine dehydrogenase deficiency
- •4. Creatinine clearance less than 30 mL/min
- •5. Impaired organ function
- •6. Metastatic disease
研究者
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