49
Participants
Start Date
November 30, 2001
Primary Completion Date
December 31, 2005
Study Completion Date
August 31, 2010
bevacizumab
Patients receive bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.
cyclophosphamide
Approximately 4 weeks after the completion of radiotherapy, patients receive cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
docetaxel
Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6.
doxorubicin hydrochloride
Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
adjuvant therapy
"After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.~Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity."
conventional surgery
After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery.
neoadjuvant therapy
"Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8.~Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
radiation therapy
Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks.
UH-Green Road, South Euclid
UH-Chagrin Highlands, Orange
UH-Southwest, Middleburg Heights
UH-Westlake, Westlake
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland
National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER