TRIAL TO COMPARE ADJUVANT ADRIAMYCIN AND CYCLOPHOSPHAMIDE IN BREAST CANCER PTS

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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. 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.