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

重组人抗 P185HER2 的 III 期多国双盲研究

• 批准号: 5218443
• 负责人: BARRY LEMBERSKY
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5218443
• 关键词: antitumor antibody; breast neoplasms; clinical research; combination cancer therapy; combination chemotherapy; cyclophosphamide; doxorubicin; female; human subject; human therapy evaluation; immunoconjugates; metastasis; monoclonal antibody; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; recombinant proteins

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.

这是一项III期随机、安慰剂对照、双盲、 比较重组抗体（rhuMAbHER 2）加 环磷酰胺和多柔比星与安慰剂加环磷酰胺和 阿霉素 约450例HER 2/neu过表达患者， 既往未接受过针对转移性乳腺癌的细胞毒性化疗 癌症将被纳入研究。 患者将被随机分配至 两个治疗组。 将对患者进行长期监测， 评估rhuMAbHER 2的有效性和安全性。