TRIAL COMPARING PREOPERATIVE DOXORUBICIN AND CYCLOPHOSPHAMIDE TO PREOPERATIVE AC

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阿霉素和环磷酰胺4个周期后给予术前或术后4个周期的泰索帝是否比术前单独给予4个周期的AC更有效地延长无病生存期和生存期。该研究还将评估术前AC后给予术前泰索帝对临床和病理局部区域肿瘤反应和乳房保护的影响。通过细针穿刺细胞学或核心针活检诊断为可触及、可手术的乳腺癌的妇女将根据年龄、临床肿瘤大小和临床淋巴结状态分层，然后随机分为三组之一。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 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.