TRIAL TO COMPARE ADJUVANT ADRIAMYCIN AND CYCLOPHOSPHAMIDE IN BREAST CANCER PTS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项前瞻性的、随机的、III期的辅助临床试验。符合条件的患者应没有转移性疾病的证据，并接受过肿块切除术或全乳房切除术加腋窝淋巴结清扫术。患者必须在MUGA或超声心动图上有高于机构正常下限的基线LVEF。患者必须事先没有接受过乳腺癌的放射治疗或全身治疗。患者的周围神经病变不得超过2级。根据阳性结节数、三苯氧胺应用、手术类型和放射治疗的选择进行分层后，患者将随机分为三组：1)AC4+他莫昔芬，然后是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措施，G-CSF作为预防细菌感染的二级预防措施。接受ATC的患者将接受G-CSF作为一级预防，环丙沙星作为预防细菌感染的二级预防。接受AC-T的患者将接受G-CSF的二级预防。所有接受肿块切除术的妇女在完成指定的化疗后都将接受乳房放射治疗。乳房切除术后照射的给药将由研究人员自行决定，但必须在随机分组时宣布。

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.