SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY

本方案描述了一项在约500例接受两种或多种细胞毒性化疗方案治疗转移性乳腺癌后复发的HER 2过表达患者中进行的重组人源化抗p185 HER 2单克隆抗体（rhuMAb HER 2）的多中心、扩大使用、开放标签、安全性研究。 由于可用的药物供应非常有限，将根据每季度入组100例患者的假设，通过抽签随机选择符合条件的患者，持续5个季度。本研究将涉及不同地理位置的研究中心，以便广泛使用这种新药。 在筛选合格性后，国家癌症研究所的治疗转诊中心将把患者转诊到最近的参与中心。 本研究的主要目的是：a）为HER 2过表达转移性乳腺癌患者提供rhuMA B HER 2治疗途径; B）表征rhuMA B HER 2单药治疗或与化疗或激素治疗联合治疗的安全性特征。

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.