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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究将评估Herceptin在HER2蛋白过度表达的结节阳性乳腺肿瘤患者中的价值。本次第三阶段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)治疗后每周在紫杉醇中添加赫赛汀(H)的毒性。如果研究组(AC-T+H)的心脏毒性发生率在方案设定的范围内，研究将进入第二阶段。第二阶段将增加患者的收益，以评估在化疗中加入赫赛汀在延长生存期和无病生存期(S)和无病生存期(DFS)方面的有效性。

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).