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RHUMABHER2/CYCLOPHOSPHAMIDE/DOXORUBICIN AND PLACEBO/CYCLOPHOSPHAMIDE/DOXORUCINB

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：
6304687
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
项目类别：
财政年份：
1999
资助国家：
美国
项目状态：
已结题
起止时间：
1999-12-01 至 2000-11-30
来源：
https://reporter.nih.gov/project-details/6304687
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

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中文摘要
翻译
这是一项第三阶段的随机、安慰剂对照、双盲、跨国研究，比较重组抗体(RhuMAbHER2)加环磷酰胺和阿霉素与安慰剂加环磷酰胺和阿霉素。大约450名HER2/neu过度表达的患者将参加这项研究，这些患者以前没有接受过转移性乳腺癌的细胞毒性化疗。患者将被平均随机分为两个治疗组之一。随着时间的推移，将对患者进行监测，以评估rhuMAbHER2的有效性和安全性。
英文摘要
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 equally randomized to one of two treatment groups. Patients will be monitored over time to evaluate the efficiency & safety of rhuMAbHER2.
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NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
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