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

这是一项III期随机、安慰剂对照、双盲、 比较重组抗体（rhuMAbHER 2）+的多国研究 环磷酰胺和多柔比星与安慰剂+环磷酰胺和 阿霉素 约450例HER 2/neu过表达患者 既往未接受过细胞毒性化疗治疗转移性乳腺癌的患者 癌症将被纳入研究。 患者将同样 随机分配至两个治疗组之一。 将监测患者 以评估rhuMAbHER 2的有效性和安全性。

This is a Phase III randomized, placebo-controlled, double-blind, multinational study comparing recombinant antibody (rhuMAbHER2) + cyclophosphamide & doxorubicin with placebo + cyclophosphamide & 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 equally randomized to one of two treatment groups. Patients will be monitored over time to evaluate the efficiency & safety of rhuMAbHER2.