TRIAL COMPARING PREOPERATIVE DOXORUBICIN AND CYCLOPHOSPHAMIDE TO PREOPERATIVE AC

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来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本研究的主要目的是确定在术前阿霉素和环磷酰胺治疗4个周期后，术前或术后给予泰索帝治疗4个周期是否比术前单独AC治疗4个周期更有效地延长无病生存期和生存期。本研究还将评价术前AC后术前泰索帝给药对临床和病理局部肿瘤缓解和乳房保护的影响。通过细针穿刺细胞学或空芯针活检诊断为可触及、可手术乳腺癌的女性将按年龄、临床肿瘤大小和临床淋巴结状态分层，然后随机分配至三组之一。在所有三组中，将在每个周期的术前化疗后获得肿瘤测量值。将在完成所有术前化疗后和手术前进行缓解评估。对于第II组患者，将在AC化疗完成后进行额外的缓解评估。I组和II组接受肿块切除术的患者将在术后恢复后接受术后放疗。第三组接受乳房肿瘤切除术的患者将在术后第四个周期泰索帝治疗后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 Taxotere given after four cycles of preoperative Adriamycin and cyclophosphamide will more effectively prolong disease-free survival and survival than do four cycles of preoperative AC alone. The study will also evaluate the effect of the administration of preoperative Taxotere after preoperative AC with respect to clinical and pathologic loco-regional tumor response and breast conservation. Women with palpable, operable carcinoma of the breast diagnosed by fine-needle aspiration cytology or by core needle biopsy will be stratified by age, clinical tumor size, and clinical nodal status, then randomized to one of three groups. 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.