SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY

这项协议描述了一项多中心、扩大访问、开放标记的重组人源化抗p185 HER2单抗(RhuMAb HER2)的安全性研究，研究对象是大约500名HER2过表达的患者，这些患者在接受两种或更多细胞毒化疗方案治疗转移性乳腺癌后复发。由于可用药物供应非常有限，符合条件的患者将根据每季度100名患者的登记假设随机选择，为期五个季度。地理上不同的中心将参与这项研究，以允许这种新制剂的广泛应用。在筛选合格后，国家癌症研究所的治疗转诊中心将把患者转介到最近的参与中心。这项研究的主要目标是a)为HER2过度表达的转移性乳腺癌患者提供rhuMAb HER2，以及b)表征rhuMAb HER2单独或与化疗或激素治疗联合使用的安全性。

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 Cancer Institute's Treatment Referral Center will refer patients to the closest participating center. The primary objectives of the study are a)to provide access to rhuMAb HER2 to patients with HER2 overexpressing metastatic breast cancer and b)to characterize the safety profile of rhuMAb HER2 alone or in combination with chemotherapy or hormonal treatment.