PHASE III MULTINATIONAL DOUBLE-BLIND STUDY OF RECOMBINANT HUMAN ANTI-P185HER2

这是一项第三阶段的随机、安慰剂对照、双盲、 比较重组抗体(RhuMAbHER2)Plus的多国研究 环磷酰胺和阿霉素加安慰剂加环磷酰胺和 阿霉素。大约450名HER2/neu过度表达的患者 未接受过细胞毒化疗的转移性乳房 癌症将被纳入这项研究。病人将被随机分成一组 两个治疗组。随着时间的推移，将对患者进行监测 评价rhuMAbHER2的疗效和安全性。

This is a Phase III randomized, placebo-controlled, double-blind, multinational study comparing recombinant antibody (rhuMAbHER2) plus cyclophosphamide and doxorubicin with placebo plus cyclophosphamide and doxorubicin. Approximately 450 patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer will be enrolled in the study. Patients will be randomized to one of two treatment groups. Patients will be monitored over time to evaluate the efficacy and safety of rhuMAbHER2.