NSABP B-28

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。本研究的主要目的是确定在具有一个或多个组织学阳性腋窝淋巴结的可手术乳腺癌患者中，在术后4个周期的阿霉素（A）和环磷酰胺（C）后给予4个周期的泰素是否比术后4个周期的AC更有效地延长无病生存期和生存期。 患者应该没有转移性疾病的证据，并且应该接受乳房肿瘤切除术加腋窝淋巴结清扫术或全乳房切除术加腋窝淋巴结清扫术。根据阳性腋窝淋巴结数量、他莫昔芬给药和手术类型进行分层后，患者将被随机分配至两组之一。组I将接受4个周期的A和C，分别以60 mg/m2和600 mg/m2给药，每21天一次。第II组将接受4个周期的AC治疗，如第I组，随后接受4个周期的紫杉醇治疗，剂量为225 mg/m2，每21天输注3小时。从给予其指定化疗的第一天开始，年龄>/=50岁的患者和患有ER阳性或PgR阳性肿瘤的<50岁的患者将接受20 mg p.o.每天一次至少五年。两组中接受肿块切除术的所有患者将在完成指定的化疗和任何毒性消退后接受术后放疗。本研究的目的是确定在可手术的乳腺癌和组织学阳性腋窝淋巴结患者中，术后4个周期AC后给予4个周期紫杉醇是否比术后4个周期AC更有效地延长无病生存期和生存期。

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 primary aim of this study is to determine whether four cycles of Taxol given after four cycles of postoperative Adriamycin (A) and Cyclophosphamide (C) will more effectively prolong disease-free survival and survival than do four cycles of postoperative AC alone in patients with operable breast cancer who have one or more histologically positive axillary lymph nodes. Patients should have no evidence of metastatic disease and should have undergone either lumpectomy plus axillary node dissection or total mastectomy plus axillary node dissection. Following stratification by number of positive axillary nodes, tamoxifen administration, and type of surgery, patients will be randomly assigned to one of two groups. Group I will receive four cycles of A and C given at 60 mg/m2 and 600 mg/m2, respectively, every 21 days. Group II will receive four cycles of AC as in Group I, followed by four cycles of Taxol given at 225 mg/m2 as a three-hour infusion every 21 days. Beginning on the first day of administration of their assigned chemotherapy, patients >/=50 years of age and those <50 years of age with tumors that are ER-positive or PgR-positive will receive tamoxifen at 20 mg p.o. once daily for at least five years. All patients in both groups who undergo a lumpectomy, will receive postoperative radiotherapy after completion of their assigned chemotherapy and after any toxicity has resolved. The objective of this study is to determine whether four cycles of postoperative Taxol given after four postoperative AC will more effectively prolong disease-free survival and survival than will be four cycles of postoperative AC alone in patients with operable breast cancer and histologically positive axillary nodes.