CHEMOTHERAPY REGIMENS IN WOMEN WITH NODE-POSITIVE BREAST CANCER

女性淋巴结阳性乳腺癌的化疗方案

• 批准号: 7376334
• 负责人: WILLIAM MCKINNON
• 金额: $ 0.87万
• 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/7376334
• 关键词: CHEMOTHERAPY; REGIMENS; WOMEN; NODE; POSITIVE

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这三期辅助治疗试验node-positive乳腺癌的女性将比较三个方案的化疗:1)TAC:多烯紫杉醇、阿霉素,和环磷酰胺每3周6周期2)DD AC-P:阿霉素/环磷酰胺每2周4周期后跟紫杉醇每2周4周期3)DD AC-PG:阿霉素/环磷酰胺每2周4周期后跟紫杉醇+吉西他滨每2周4周期研究的主要目标是:1)确定阿霉素+环磷酰胺+紫杉醇+吉西他滨是否优于多西他赛+阿霉素+环磷酰胺方案，以及阿霉素+环磷酰胺+紫杉醇单独方案在改善无病生存方面是否优于阿霉素+环磷酰胺+紫杉醇单独方案；2)比较TAC和DD AC-P的相对DFS。次要目的是：1)确定DD AC-PG方案在改善生存率、无复发间隔和远端无复发间隔方面是否优于TAC方案以及DD AC-P方案；2)比较TAC和DD AC-P方案的S、RFI和DRFI； 3)确定DD AC-PG、TAC和DD AC-P方案的相对毒性。