TRIAL TO COMPARE ADJUVANT ADRIAMYCIN AND CYCLOPHOSPHAMIDE IN BREAST CANCER PTS

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。这是一项前瞻性、随机、III期辅助临床试验。符合条件的患者应无转移性疾病的证据，并已接受乳房肿瘤切除术或全乳切除术加腋窝淋巴结清扫。患者在MUGA或超声心动图上的基线LVEF必须大于该机构的正常下限。患者必须没有接受过乳腺癌的放射治疗或全身治疗。患者不能有超过2级的周围神经病变。根据阳性淋巴结数、他莫昔芬给药、手术类型和放疗选择进行分层后，患者将随机分为三个治疗组：1)ac4 +他莫昔芬，t4；2) at4 +他莫昔芬；或3)atc4 +他莫昔芬。接受AT治疗的患者将给予环丙沙星作为一级预防药物，G-CSF作为二级预防药物来预防细菌感染。接受ATC的患者将给予G-CSF作为一级预防，环丙沙星作为二级预防，以防止细菌感染。接受AC-T治疗的患者将接受G-CSF的二级预防。所有接受乳房肿瘤切除术的妇女将在完成指定的化疗后接受乳房照射。乳房切除术后照射的管理将由研究者自行决定，但必须在随机分组时声明。

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. This is a prospective, randomized, phase III, adjuvant clinical trial. Eligible patients should have no evidence of metastatic disease and have undergone either lumpectomy or total mastectomy plus axillary node dissection. Patients must have a baseline LVEF on MUGA or echocardiogram greater than the institution's lower limit of normal. Patients must not have received prior radiation therapy or systemic therapy for breast cancer. Patients must not have greater than grade 2 peripheral neuropathy. Following stratification by number of positive nodes, tamoxifen administration, type of surgery, and choice of radiotherapy, patients will be randomized into one of three treatment groups: 1) AC 4 + tamoxifen followed by T 4; 2) AT 4 + tamoxifen; or 3) ATC 4 + tamoxifen. Patients receiving AT will be given ciprofloxacin as primary prophylaxis and G-CSF as secondary prophylaxis against bacterial infection. Patients receiving ATC will be given G-CSF as primary prophylaxis, and ciprofloxacin as secondary prophylaxis against bacterial infection. Patients receiving AC-T will receive secondary prophylaxis with G-CSF. ALl women treated with lumpectomy will receive breast irradiation after completion of assigned chemotherapy. Administration of post-mastectomy irradiation will be at the discretion of the investigator but must be declared at the time of randomization.