JPRN-UMIN000000806已完成2 期
Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial - TBCRG03
Tokai Breast Cancer Clinical Research Group (TBCRG)0 个研究点目标入组 50 人开始时间: 2007年9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
- 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
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1.As neoadjuvant and adjuvant therapy , treated hormone therapy and chemotherapy 2.HER2 / neu gene overexpressed or amplified 3.A history of whitlow and cold allergy 4.Bilateral breast cancer and Inflammatory breast cancer 5.Uncontrolled medical conditions 6.Hepatitis B 7.A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 8.Sever infection 9.Peripheral neuropathy 10.Pleural or pericardial effusion requiring treatment 11.Pregnant or lactating women and women of child bearing potential not using contraception. 12.Grade2-4 Severe peripheral edema. 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.A history of hypersensitivity reaction to drugs formulated with Polysorbate 80 15.Severe psychiatric disorders 16.Patients judged by the investigator to be unfit to be enrolled into the study
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