39
Participants
Start Date
February 28, 1999
Primary Completion Date
November 30, 2001
Study Completion Date
January 31, 2013
filgrastim
Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each 2 week course.
CMF regimen
Stratum I and II: receive cyclophosphamide, methotrexate, and fluorouracil (CMF) for 4 courses
docetaxel
Docetaxel IV over 1 hour on days 43, 57, and 71.
doxorubicin hydrochloride
Doxorubicin IV on days 1, 15, and 29.
tamoxifen citrate
Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years.
autologous bone marrow transplantation
Stratum III:may receive high dose chemotherapy with stem cell support
surgical procedure
Fourteen to 21 days following preoperative chemotherapy, patients undergo a radical, modified radical, or breast sparing surgery plus axillary lymph node dissection.
radiation therapy
Radiotherapy is administered 5 days a week for 5.5 weeks.
Metro Health Medical Center, Cleveland
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland
National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER