JPRN-UMIN000035869尚未招募未知
Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer - Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab
The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience0 个研究点目标入组 30 人开始时间: 2019年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- •1.Without previous chemotherapy 2.With brain metastasis with symptom 3.With active another cancer 4.With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 6 months, arrhythmia that need treat, valvular heart disease 5.With dyspnea at rest due to metastatic lung lesion 6.Insufficient organ function meeting following criteria Neutrophil <1500/mm2 Platelet <100000/mm2 Hemoglobin <8.0g/dL AST(GOT)>100IU/L (with liver function disorder by metastasis) ALT (GPT) >100IU/L (with liver function disorder by metastasis) Serum total bilirubin <2.0mg/dL Serum creatinine >2.0mg/dL or 177umol/L 7.With uncontrollable systemic disease (cardiovascular/pulmonary/metabolic, protracted wound healing, ulcer and bone fracture) 8.With uncontrollable hypercalcemia even by Bisphosphonate or denosumab 9.Pregnant or nursing women 10.Infection or possible infection associated with clinical symptoms 11.With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab. 12.Cases who physician judged improper to entry this trial
研究者
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