NSABP B-28

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。 这项研究的主要目的是确定在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，在术后四个周期的阿霉素(A)和环磷酰胺(C)后给予四个周期的紫杉醇是否比单独使用四个周期的AC更有效地延长无瘤生存期和生存期。 患者应该没有转移性疾病的证据，并且应该接受肿块切除加腋窝淋巴结清扫或全乳房切除加腋窝淋巴结清扫。根据腋窝阳性结节数目、三苯氧胺给药和手术类型进行分层后，患者将被随机分配到两组之一。I组分别以60 mg/m~2和600 mg/m~2给药，每21天一次，共4个周期。第二组与第一组相同，先接受四个周期的AC，然后再以225 mg/m2的紫杉醇进行四个周期的静脉滴注，每21天一次，每次3小时。从接受指定化疗的第一天开始，50岁的患者和那些ER阳性或PGR阳性的肿瘤患者将接受他莫昔芬20毫克的口服。至少五年内每天服用一次。两组中所有接受肿瘤切除术的患者，在完成指定的化疗和任何毒性消除后，都将接受术后放射治疗。 本研究的目的是确定在可手术的乳腺癌和腋窝淋巴结组织学阳性的患者中，术后四个周期的紫杉醇在术后四个周期应用是否会比单独应用四个周期的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.