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SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY

SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY
重组单克隆抗体的安全性研究
批准号：
6264180
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：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6264180
关键词：
breast neoplasms clinical research clinical trial phase I human subject human therapy evaluation monoclonal antibody neoplasm /cancer immunotherapy recombinant proteins

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中文摘要
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英文摘要
This protocol describes a multicenter expanded access open label safety study of recombinant humanized anti-p185 HER2 monoclonal antibody (rhuMAb HER2) in approximately 500 patients with HER2 overexpression who have relapsed following two or more cytotoxic chemotherapy regimens for metastatic breast cancer. Due to the very limited drug supply available, eligible patients will be randomly selected by lottery based on an enrollment assumption of 100 patients per quarter for five quarters. Geographically diversed centers will be involved in the study in order to allow widespread availability of this new agent. Following screening for eligibility, the National Center Institutes Treatment Referral Center will refer patietns to the closest participating center.
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NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
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NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
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