NSAPB-38: COMPARISON OF THREE CHEMOTHERAPY REGIMENS IN WOMEN WITH BREAST CANCER

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。本试验的目的是比较三种化疗方案对有限淋巴结受累的乳腺癌患者的疗效。这项多中心随机试验将测试其毒性、安全性和有效性。辅助治疗已被证明可以延长乳腺癌患者的生命，研究人员希望能提出一种有效、安全且耐受性良好的治疗方案。4800名患有单侧非转移性乳腺癌的女性将被招募参加这项研究（10名在NYUSOM）。女性可能有淋巴结疾病，但没有对侧淋巴结受累。患者将被随机分配到3个方案中的一个：1)多西他赛/阿霉素/环磷酰胺（TAC）；2)剂量密集（DD）多柔比星/环磷酰胺其次是DD紫杉醇（DD AC-P）；3) DD AC，其次是DD紫杉醇加吉西他滨（DD AC- pg）。他们将接受他们通常会接受的所有其他治疗（放疗、filgastrim等）。主要终点是无病生存期。次要终点包括复发和无复发生存期

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 object of this trial is to compare three regimens of chemotherapy in patients with breast cancer and limited nodal involvement. The toxicities, safety and efficacy will be tested in this multicenter randomized trial. Adjuvant therapy has been shown to prolong life in women with breast cancer, and the investigators hope to come up with an effective, safe and well-tolerated regimen. 4800 women with unilateral, non-metastatic breast cancer will be recruited to take part in this study (10 at NYUSOM). Women may have nodal disease but not contra lateral lymph node involvement. Patients will be randomized to one of 3 regimens: 1) Docetaxel/Doxorubicin/Cyclophosphamide (TAC); 2) Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC-P); 3) DD AC Followed by DD Paclitaxel plus Gemcitabine (DD AC-PG). They will be given all the other therapies they would normally receive (radiation, filgastrim, etc). The primary endpoint is disease-free survival. Secondary endpoints include recurrence and recurrence-free survi