RHUMABHER2/CYCLOPHOSPHAMIDE/DOXORUBICIN AND PLACEBO/CYCLOPHOSPHAMIDE/DOXORUCINB

RHUMABHER2/环磷酰胺/阿霉素和安慰剂/环磷酰胺/阿霉素

• 批准号: 6219253
• 负责人: ADAM M BRUFSKY
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6219253
• 关键词: antineoplastic antibiotics; breast neoplasms; clinical research; combination cancer therapy; cyclophosphamide; doxorubicin; drug adverse effect; drug screening /evaluation; human subject; 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 & 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 equally randomized to one of two treatment groups. Patients will be monitored over time to evaluate the efficiency & safety of rhuMAbHER2.

这是一项III期随机、安慰剂对照、双盲、多国研究，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多柔比星。 本研究将入组约450例既往未接受过细胞毒性化疗治疗转移性乳腺癌的HER 2/neu过表达患者。 患者将被平均随机分配至两个治疗组之一。 将随时间监测患者以评估rhuMAbHER 2的有效性和安全性。