NSABP B-27

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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.