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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：
6275829
负责人：
ADAM M BRUFSKY
金额：
$1.91万
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：
1997
资助国家：
美国
项目状态：
已结题
起止时间：
1997-12-01 至 1998-11-30
来源：
https://reporter.nih.gov/project-details/6275829
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。 患者将被平等随机分配 两个治疗组之一。 将对患者进行长期监测， 评估rhuMAbHER 2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) + 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.
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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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