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

比较乳腺癌中六周期 FEC 与四周期 AC 的试验

• 批准号: 7376310
• 负责人: EUGENE A WOLTERING
• 金额: $ 0.41万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376310
• 关键词: TRIAL; COMPARING; SIX; CYLES; FEC

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.

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。本III期试验的主要目的是评估是否：5-氟尿嘧啶（5-FU）、表阿霉素和环磷酰胺（FEC-100）6个周期的方案在延长淋巴结阴性乳腺癌妇女的无病生存期（DFS）方面上级阿霉素和环磷酰胺（AC）4个周期的方案。B.化疗（AC或FEC-100）联合塞来昔布在延长相同患者人群的DFS方面上级单用化疗。 B-36还将评估FEC-100方案是否上级AC方案，以及塞来昔布联合化疗在延长生存期、无复发间期和无远处复发间期方面是否上级单独化疗。此外，将确定治疗组之间在不良反应、症状、生活质量、化疗后闭经和心脏功能方面的差异。B-36研究评价了在HER-2和/或Topo-II基因扩增的病例中FEC-100方案是否上级AC方案，以及塞来昔B的获益是否在肿瘤表达考克斯-2的患者队列中更明显。