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

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-45
Application #
7378357
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
45
Fiscal Year
2006
Total Cost
$1,870
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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