TRIAL TO COMPARE ADJUVANT ADRIAMYCIN AND CYCLOPHOSPHAMIDE IN BREAST CANCER PTS

比较阿霉素和环磷酰胺辅助治疗乳腺癌 PTS 的试验

• 批准号: 7376252
• 负责人: EUGENE A WOLTERING
• 金额: $ 0.25万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376252
• 关键词: TRIAL; COMPARE; ADJUVANT; ADRIAMYCIN; CYCLOPHOSPHAMIDE

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.

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来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项前瞻性、随机、III期辅助临床试验。符合条件的患者应该没有转移性疾病的证据，并且已经接受了乳房肿瘤切除术或全乳房切除术加腋窝淋巴结清扫术。患者的MUGA或超声心动图基线LVEF必须大于机构的正常下限。患者不得接受过既往放射治疗或乳腺癌全身治疗。患者不能有大于2级的周围神经病变。 根据阳性淋巴结数量、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之一：1）AC 4 +他莫昔芬，然后是T 4; 2）AT 4 +他莫昔芬;或3）ATC 4 +他莫昔芬。接受AT的患者将给予环丙沙星作为一级预防，G-CSF作为二级预防细菌感染。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细菌感染。接受AC-T的患者将接受G-CSF二级预防。接受肿块切除术治疗的ALL女性在完成指定的化疗后将接受乳房照射。乳房切除术后放疗的给药将由研究者决定，但必须在随机化时声明。