214
Participants
Start Date
August 31, 2006
Primary Completion Date
October 31, 2011
Study Completion Date
October 31, 2011
Doxorubicin and cyclophosphamide (AC) + bevacizumab
"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* doxorubicin 60 mg/m\^2 IV push or infusion followed by cyclophosphamide 600 mg/m\^2 IV push or infusion~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
Docetaxel (T) + bevacizumab
"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* docetaxel 100 mg/m\^2 IV~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy~Note: The starting dose of docetaxel was reduced to 75 mg/m\^2 if toxicity occurred that met the criteria for doxorubicin dose reduction"
Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab
"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* doxorubicin 50 mg/m\^2 IV push or infusion followed by cyclophosphamide 500 mg/m\^2 IV push or infusion followed by docetaxel 75 mg/m\^2~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab
"For every 3-week cycle~* bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by~* docetaxel in 75 mg/m\^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by~* trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2)~* Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy"
Bevacizumab and trastuzumab maintenance therapy
"* bevacizumab 15 mg/kg was infused IV followed by~* trastuzumab 6 mg/kg IV~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."
Bevacizumab maintenance therapy
"\- bevacizumab 15 mg/kg was infused IV~Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed."
Sanofi-Aventis Administrative Office, Bridgewater
Lead Sponsor
Sanofi
INDUSTRY