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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项试验的目的是比较三种化疗方案在乳腺癌和局限性淋巴结转移患者中的应用。毒性、安全性和有效性将在这项多中心随机试验中进行测试。辅助治疗已被证明可以延长女性乳腺癌患者的生命，研究人员希望能提出一种有效、安全和耐受性良好的治疗方案。4800名患有单侧、非转移性乳腺癌的妇女将被招募参加这项研究(NYUSOM有10名)。女性可能有结节病，但不会累及对侧淋巴结。患者将被随机分成3种方案之一： 1)多西紫杉醇/阿霉素/环磷酰胺(TAC)； 2)剂量密度(DD)阿霉素/环磷酰胺+DD紫杉醇(DD AC-&GT；P)；3)DD AC+DD紫杉醇+吉西他滨(DD AC-&GT；PG)。 他们将接受他们通常会接受的所有其他治疗(放射治疗、非司匹林等)。主要终点是无病生存。次要终点包括复发和无复发存活率。

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 survival.