16
Participants
Start Date
July 31, 2000
Primary Completion Date
June 30, 2006
Study Completion Date
September 30, 2012
filgrastim
Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \> 10,000/uL x1 day after the nadir cycles 1-3.
cyclophosphamide
cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3
doxorubicin hydrochloride
Patients then receive doxorubicin IV on day 1.
paclitaxel
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3
tamoxifen citrate
tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed
adjuvant therapy
Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
radiation therapy
Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
UH-LUICC, Mentor
UH-Chagrin Highlands, Orange
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland
National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER