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.
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