21
Participants
Start Date
October 31, 2006
Primary Completion Date
December 31, 2010
Study Completion Date
March 31, 2011
Lapatinib
1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
Doxorubicin
60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
Cyclophosphamide
600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
Docetaxel
100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Pegfilgrastim
6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
Filgrastim
300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
Dexamethasone
8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
Trastuzumab
Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year
Stanford University School of Medicine, Stanford
Santa Clara Valley Medical Center, San Jose
Collaborators (2)
GlaxoSmithKline
INDUSTRY
Sanofi
INDUSTRY
George Albert Fisher
OTHER