CHEMOTHERAPY REGIMENS IN WOMEN WITH NODE-POSITIVE BREAST CANCER

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来源获得了主要资金，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。这项针对淋巴结阳性乳腺癌女性的III期辅助治疗试验将比较三种化疗方案：1）TAC：多西他赛、多柔比星和环磷酰胺，每3周一次，共6个周期; 2）DD AC-P：多柔比星/环磷酰胺，每2周一次，共4个周期; 3）DD AC-PG：紫杉醇，每2周一次，共4个周期。多柔比星/环磷酰胺，每2周一次，持续4个周期，然后紫杉醇加吉西他滨，每2周一次，持续4个周期。1）确定剂量密集的多柔比星和环磷酰胺随后是剂量-密集紫杉醇和吉西他滨将上级多西他赛方案，多柔比星和环磷酰胺以及剂量密集的多柔比星和环磷酰胺随后单独的剂量密集的紫杉醇的方案在改善无病生存方面的作用，以及2）比较TAC和DD AC的相对DFS-次要目的是：1）确定DD AC-PG方案在改善生存率、无复发间期和无远处复发间期方面是否上级TAC方案以及DD AC-P方案，2）比较TAC和DD AC-P之间的S、RFI和DRFI，3）确定DD AC-PG、TAC和DD AC-P的相对毒性。

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 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.