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

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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.