127
Participants
Start Date
March 31, 2007
Primary Completion Date
August 31, 2010
Study Completion Date
August 31, 2010
Docetaxel
"75 mg/m\^2 administered IV on Day 1 for Cycles 1-6~All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg)."
Doxorubicin
50 mg/m\^2 administered IV on Day 1 for Cycles 1-6
Carboplatin
6 mg/mL/min (target area under the curve \[AUC\] dose) administered IV on Day 1 for Cycles 1-6
Cyclophosphamide
500 mg/m\^2 administered IV on Day 1 for Cycles 1-6
Trastuzumab
A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy
Bevacizumab
15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy
Sanofi-Aventis Administrative Office, Bridgewater
Lead Sponsor
Sanofi
INDUSTRY