CHEMOTHERAPY REGIMENS IN WOMEN WITH NODE-POSITIVE 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. This Phase III adjuvant therapy trial for women with node-positive breast cancer will compare three regimens of chemotherapy: 1) TAC: docetaxel, doxorubicin, and cyclophosphamide every 3 weeks for 6 cycles 2) DD AC-P: doxorubicin/cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel every 2 weeks for 4 cycles 3) DD AC-PG: doxorubicin/cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel plus gemcitabine every 2 weeks for 4 cycles The primary aims of the study are to: 1) determine whether a regimen of dose-dense doxorubicin and cyclophosphamide followed by dose-dense paclitaxel and gemcitabine will be superior to a regimen of docetaxel, doxorubicin and cyclophosphamide as well as to a regimen of dose-dense doxorubicin and cyclophosphamide followed by dose-dense paclitaxel alone in improving disease-free survival and 2) compare the relative DFS of TAC and DD AC-P. The secondary aims are to: 1) determine whether a regimen of DD AC-PG will be superior to a regimen of TAC as well as to a regimen of DD AC-P in improving survival, recurrence-free interval and distant recurrence-free interval, 2) compare S, RFI and DRFI between TAC and DD AC-P and 3) determine the relative toxicities of DD AC-PG, TAC and DD AC-P.