NSABP B-27

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。 本研究的主要目的是确定阿霉素(A)和环磷酰胺(C)(AC)在术前或术后应用四个周期的紫杉醇是否能比单独应用四个周期的AC更有效地延长无病生存期(DFS)和生存期(S)。这项研究还将评估术前AC后应用泰素对临床和病理局部肿瘤反应和保护的影响。根据年龄、临床肿瘤大小和临床结节状况诊断为可触及、可手术的乳腺癌的妇女，然后随机分为三组之一。I组接受四个周期的术前A和C，分别为60 mg/m~2和500 mg/m~2，每21天一次，然后手术(肿块切除和外周淋巴结清扫，或改良的乳腺癌根治术)。组II与组I相同，于术前接受4个周期的AC，然后在手术后每21天静脉滴注泰索帝100 mg/m2，每1小时1个周期。III组将接受4个周期的AC，如I组和II组，然后手术和术后4个周期的泰索帝，如II组。从他们指定的化疗的第一天开始，所有三组都将接受他莫昔芬20 mg的口服。每天一次，连续5年。在所有三组中，肿瘤测量都将在每个术前化疗周期后进行。在完成所有术前化疗后和手术前将进行疗效评估。对于II组患者，在AC化疗完成后将进行额外的疗效评估。第I组和第II组接受肿瘤切除术，术后恢复后接受放射治疗。组III接受肿瘤切除术，术后泰索帝第四周期恢复后接受术后放射治疗。

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 preoperative or postoperative Taxotene given after for cycles of preoperative Adriamycin; (A) and cyclophosphamide (C) (AC) will more effectively prolong disease-free survival (DFS) and survival (S) than do four cycles of preoperative AC alone. The study will also evaluate the effect of the administration of preoperative Taxotene after preoperative AC with respect to clinical and pathologic loco-regional tumor response and conservation. Women with palpable, operable carcinoma of the breast diagnosed by age, clinical tumor size, and clinical nodal status, then randomized to one of three groups. Group I will receive four cycles of preoperative A and C given at 60 mg/m2 and 500 mg/m2, respectively, every 21 days followed by surgery (lumpectomy and exillary node dissection, or modified radical mastectomy). Group II will receive four cycles of preoperative AC as in group I, followed by four cycles of preoperative Taxotere at 100 mg/m2 as a 1-hour infusion every 21 days followed by surgery. Group III will receive four cycles as AC as in groups I and II, followed by surgery and by four cycles of postoperative Taxotere, as in group II. Beginning on the first day of administration of their assigned chemotherapy, all three groups will receive tamoxifen at 20 mg p.o. once daily for 5 years. In all three groups, tumor measurements will be obtained after each cycle of preoperative chemotherapy. Assessment of response will be performed after completion of all preoperative chemotherapy and before surgery. For patients in group II, an additional assessment of response will be performed after completion of AC chemotherapy. Patients in groups I and II who undergo lumpectomy will receive postoperative radiotherapy after their recovery from surgery. Patients in group III who undergo lumpectomy will receive postoperative radiotherapy after their recovery from the fourth cycle of postoperative Taxotere.