THREE CHEMOTHERAPY REGIMENS IN WOMEN WITH NODE-POSITIVE BREAST CANCER

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。所列机构为中心机构，不一定为研究者机构。本研究的主要目的是确定剂量密集的多柔比星和环磷酰胺随后是剂量密集的紫杉醇和吉西他滨的方案是否上级多西他赛，多柔比星，和环磷酰胺每3周给药一次，以及剂量密集的多柔比星和环磷酰胺随后单独剂量密集的紫杉醇方案在改善无病生存期方面的作用，并比较相对疾病-TAC和剂量密集的阿霉素环磷酰胺随后紫杉醇的自由存活。 本研究将在可手术乳腺癌伴组织学阳性腋窝淋巴结的女性中进行。患者将根据阳性淋巴结数量、激素受体状态、手术类型和计划的放疗进行分层。分层后，患者将被随机分配至三种化疗方案之一。ER阳性和/或PR阳性肿瘤的女性应在完成化疗后接受至少5年的激素治疗。所有做过乳房肿块切除术的妇女都将接受全乳房照射。将由研究者决定前瞻性确定胸壁和局部淋巴结照射，并将其用作分层因素。 对于同意样本库的患者，将提交索引肿瘤块以及诊断为对侧乳腺癌后采集的肿瘤块。将在基线时、首次局部或远处复发时以及局部或远处复发前发生对侧乳腺癌时采集血清。如果首次复发是同侧乳腺肿瘤复发，则还将在随后首次区域或远处复发时采集血清样本。 该研究将在约4年的时间内入组4800例患者。LSUHSC将在当地招募约10名患者。预计将在研究开始后约7年进行确定性分析。

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 aims of this study are to determine whether the regimen of dose-dense doxorubicin and cyclophosphamide followed by dose-dense paclitaxel and gemcitabine will be superior to a regimen of docetaxel, doxorubicin, and cyclophosphamide administered every 3 weeks as well as to a regimen of dose-dense doxorubicin and cyclophosphamide followed by dose-dense paclitaxel alone in improving disease-free survival and to compare the relative disease-free survival of TAC and dose dense adiramycin cyclophosphamide followed by paclitaxel. The study will be conducted in women with operable, carcinoma of the breast with histological positive axillary nodes. Patients will be stratified by number of positive nodes, hormone receptor status, and type of surgery and planned radiotherapy. Following stratification, patients will be randomized to one of the three chemo regimens. Women with ER-positive and/or PR positive tumors should receive hormonal therapy for a minimum of 5 years following completion of chemo. All women who have had a lumpectomy will have whole breast irradiation. Chest wall and regional nodal irradiation will be prospectively determined at the discretion of the investigator and will be used as a stratification factor. For patients who agree to specimen banking index tumor blocks as well as tumor blocks collected after diagnosis of contralateral breast cancer will be submitted. Serum will be collected at baseline, at the time of first locoregional or distant recurrence, and when a contralateral breast cancer develops prior to locoregional or distant recurrence. If the first recurrence is an ipsilateral breast tumor recurrence, a serum sample will also be collected at the time of the first subsequent regional or distant recurrence. The study will enroll 4800 patients over a period of approximately 4 years. LSUHSC will enroll approximately 10 patients locally. It is anticipated that the definitive analysis will be carried out approximately seven years after study initiation.