82
Participants
Start Date
December 31, 1998
Primary Completion Date
March 31, 2012
Study Completion Date
April 30, 2013
trastuzumab
infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks
cyclophosphamide
600 mg/m2, intravenous infusion every 3 weeks for four cycles
doxorubicin hydrochloride
60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks
paclitaxel
90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®)
conventional surgery
Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
Comprehensive Cancer Center at Wake Forest University, Winston-Salem
UNC Lineberger Comprehensive Cancer Center
OTHER