TRIAL COMPARING SIX CYLES OF FEC TO FOUR CYCLES OF AC IN BREAST CANCER

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。这项第三阶段试验的主要目的是评估：a.在延长淋巴结阴性乳腺癌妇女的无病生存期(DFS)方面，6个周期的5-氟尿嘧啶(5-FU)、表阿霉素和环磷酰胺(FEC-100)方案是否优于4个周期的阿霉素和环磷酰胺(AC)。在相同的患者群体中，化疗(AC或FEC-100)联合塞来昔布在延长DFS方面优于单独化疗。B-36还将评估FEC-100方案是否优于AC方案，以及塞来昔布化疗是否在延长生存期、无复发间期和远距离无复发间期方面优于单独化疗。此外，还将确定治疗组之间在不良反应、症状、生活质量、化疗后闭经和心功能方面的差异。B-36研究评估了在HER-2和/或Topo-II基因扩增的情况下，FEC-100方案是否优于AC方案，以及塞来昔布的益处是否在肿瘤表达COX-2的一组患者中更明显。

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. The primary aims of this phase III trial are to evaluate whether: a. A regimen of 6 cycles of 5-fluorouracil (5-FU), epirubicin, and cuclophosphamide (FEC-100) is superior to 4 cycles of Adriamycin and cyclophosphamide (AC) in prolonging disease-free survival (DFS) in women with node-negative breast cancer. b. Chemotherapy (AC or FEC-100) plus celecoxib is superior to chemotherapy alone in prolonging DFS in the same patient population. B-36 will also evaluate whether the FEC-100 regimen is superior to the AC regimen and whether chemotherapy with celecoxib is superior to chemotherapy alone in prolonging survival, recurrence-free interval, and distant recurrence-free interval. Additionally, differences between the treatment groups in adverse effects, symptoms, quality of life, post-chemotherapy amenorrhea, and cardiac function will be determined. The B-36 study evaluate if the FEC-100 regimen is superior to the AC regimen in cases in which HER-2 and/or Topo-II genes are amplified, and if the benefits from celecoxib are more pronouced in a cohort of patients whose tumors express COX-2.