JPRN-UMIN000005388已完成2 期
Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer - ABI-007 Followed by FEC Neoadjuvant Chemotherapy for Breast Cancer (Randomized Phase II Trial)
Department of Breast Surgical Oncology, Showa University0 个研究点目标入组 150 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) History of sever hypersensitivity 2) Her 2 overexpression (3+ by IHC stain or 2+ and FISH positive) 3) Active other malignancies 4) Severe complications (infection, diarrhea, intestine on the paralyzed, and ileus which affect to treatment, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure interstitial pneumonia or pulmonary fibrosis, cerebrovascular accident etc.) 5) has brain metastasis with symptoms 6) has psychological illness which became a problem in practice 7) received transfusion within 2 weeks because of bleeding in gastrointestinal tract 8) sever bone suppression, renal dysfunction, and liver dysfunction 9) sever pleural effusion or ascites fluid 10) water diarrhea at registration 11) has infection or fever which suspected of infection 12) history of hypersensitivity to Nab-paclitaxel, paclitaxel or albumin 13) pregnant or possibility of pregnant 14) history of sever hypersensitivity to docetaxel or polysorbate-containing product 15) Patients judged inappropriate by physicians
研究者
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