JPRN-UMIN000021398已完成3 期
A Phase III, Open Label, Randomized, Controlled, Multicenter Study, comparing Eribulin with S1, to assess Health-related Quality of Life (HRQoL) in the Treatment of Her2 negative Metastatic Breast Cancer Patients - RESQ
CSPOR-BC0 个研究点目标入组 330 人开始时间: 2016年3月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
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 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Key exclusion criteria 1) HER2 positive 2) more than two regimens of chemotherapy for metastatic breast cancer 3) Using Eribulin or S1 before enrollment 4) Presence of Grade 3 non hematologic or hematologic toxicities 5) Lung fibrosis, interstitial pneumonitis, 6) severe cardiac dysfunction, ischemic heart disease 7) Severe pleural effusion or ascites 8) The sustained systemic steroid treatment 9) Severe allergic history against medicines 10) Pregnant or the pregnancy is doubted 11) The presence of brain metastasis requiring treatment 12) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less). 13) Bilateral breast cancer (However, registration is permitted when contralateral breast cancer is DCIS or the status of ER and HER2 is same) 14) Physician concludes that the patient's participation in this trial is inappropriate
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