JPRN-UMIN000004839
已完成
2 期
A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer - A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Kinki Multidisciplinary Breast Oncology Group0 个研究点目标入组 42 人2011年1月7日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Kinki Multidisciplinary Breast Oncology Group
- 入组人数
- 42
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- 未提供
排除标准
- •1\) Pulmonary fibrosis or pneumonia 2\) body cavity fluid whichi needs to be treated 3\)Symptomatic brain metastasis 4\) Active double cancer 5\) The diabetes that is impossible of control and high blood pressure case 6\)HBs antigen positive 7\)Heart diseases with the following items History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months Congestive heart failure Arrhythmia which needed to be treated 8\)Apparently/possibly during pregnancy or lactation expectant 9\) Serious drug allergy 10\) Judged by the investigator to be unfit to be enrolled into the study
结局指标
主要结局
未指定
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进行中(未招募)
不适用
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进行中(未招募)
不适用
Phase III study of vinflunine plus gemcitabine versus paclitaxel plus gemcitabine in patients with unresectable, locally recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapyTreatment of patients with unresectable, locally recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy or if contraindicated, a non-anthracycline based chemotherapy.MedDRA version: 7.1Level: LLTClassification code 10027475EUCTR2006-001139-23-ATPIERRE FABRE MEDICAMENT994