SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY

该方案描述了一项多中心、扩展途径、开放标签、重组人源化抗p185 HER2单克隆抗体（rhuMAb HER2）在大约500名HER2过表达患者中进行的安全性研究，这些患者在接受两种或两种以上细胞毒性化疗方案后复发转移性乳腺癌。由于可获得的药物供应非常有限，符合条件的患者将根据每个季度100名患者的登记假设随机抽取，为期5个季度。地理上不同的中心将参与这项研究，以便广泛使用这种新药物。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诊到最近的参与中心。该研究的主要目的是a)为HER2过表达转移性乳腺癌患者提供rhuMAb HER2治疗途径，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.