NSABP B-27

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。本研究的主要目的是确定术前或术后给予4个周期的紫杉醇是否优于术前给予周期的阿霉素；(A)和环磷酰胺(C) （AC）比术前单独使用4个周期AC更有效地延长无病生存期（DFS）和生存期(S)。该研究还将评估术前AC后给予术前Taxotene对临床和病理局部区域肿瘤反应和保存的影响。根据年龄、临床肿瘤大小和临床淋巴结状态诊断为可触及、可手术的乳腺癌的妇女，随机分为三组之一。组1术前分别给予60 mg/m2和500 mg/m2 4个周期的A和C，每21天一次，随后进行手术（乳房肿瘤切除和腋窝淋巴结清扫，或改良根治性乳房切除术）。与I组一样，II组接受4个周期的术前AC治疗，随后进行4个周期的术前泰索帝100 mg/m2，每21天输注1小时，然后进行手术。III组将与I组和II组一样接受4个周期的AC治疗，随后进行手术治疗，并与II组一样接受4个周期的术后泰索帝治疗。从指定化疗的第一天开始，所有三组患者将接受他莫昔芬，每次20毫克，每日一次，持续5年。在所有三组中，肿瘤测量将在每个术前化疗周期后进行。在所有术前化疗完成后和手术前进行疗效评估。对于II组患者，将在AC化疗完成后进行额外的反应评估。I组和II组行乳房肿瘤切除术的患者术后恢复后接受放疗。III组患者行乳房肿瘤切除术，术后第4周期泰索帝治疗恢复后接受术后放疗。

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 preopeartive 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.