TRIAL COMPARING SAFETY AND EFFICACY OF AC-T TO AC-T+H IN NODE-POSITIVE BREAST CA

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这项研究将评估赫赛汀在过度表达HER 2蛋白的淋巴结阳性乳腺肿瘤患者中的价值。本III期随机试验将分两个阶段进行。第一阶段将评估心脏安全性，并确定在阿霉素和环磷酰胺（AC）后每周添加赫赛汀（H）辅助紫杉醇的毒性。如果研究组（AC-T+H）的心脏毒性发生率福尔斯在方案设定的范围内，则研究将进入第二阶段。第二阶段将增加患者招募，以评估在化疗中添加赫赛汀在延长生存期（S）和无病生存期（DFS）方面的疗效。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will evaluate the worth of Herceptin in patients with node-positive breast tumors that overexpress the HER2 protein. This phase III, randomized trial will be conducted in two stages. The first stage will evaluate cardiac safety and determine the toxicities of adding weekly Herceptin (H) to adjuvant Taxol following Adriamycin and cyclophosphamide (AC). Provided that the incidence of cardiac toxicity in the study arm (AC-T+H) falls within the boundaries set by the protocol, the study will proceed to the second stage. The second stage will increase patient accrual to allow an evaluation of the efficacy of adding Herceptin to chemotherapy in prolonging survival (S) and disease-free survival (DFS).