NSAPB-38: COMPARISON OF THREE CHEMOTHERAPY REGIMENS IN WOMEN WITH BREAST CANCER

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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. The object of this trial is to compare three regimens of chemotherapy in patients with breast cancer and limited nodal involvement. The toxicities, safety and efficacy will be tested in this multicenter randomized trial. Adjuvant therapy has been shown to prolong life in women with breast cancer, and the investigators hope to come up with an effective, safe and well-tolerated regimen. 4800 women with unilateral, non-metastatic breast cancer will be recruited to take part in this study (10 at NYUSOM). Women may have nodal disease but not contra lateral lymph node involvement. Patients will be randomized to one of 3 regimens: 1) Docetaxel/Doxorubicin/Cyclophosphamide (TAC); 2) Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC-P); 3) DD AC Followed by DD Paclitaxel plus Gemcitabine (DD AC-PG). They will be given all the other therapies they would normally receive (radiation, filgastrim, etc). The primary endpoint is disease-free survival. Secondary endpoints include recurrence and recurrence-free survi