15
Participants
Start Date
October 31, 2008
Primary Completion Date
October 31, 2013
Study Completion Date
October 31, 2013
Lapatinib
1000 mg taken by every day by mouth (PO) weeks 1 and 2; then starting day 15 for 12 weeks (weeks 3 to 14) daily 750 mg PO. Week 15, second combination treatment consisting of lapatinib (1,000 mg orally once daily) combined with FEC7.
Paclitaxel
80 mg/m\^2 intravenously over 1 hour weekly for 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.
5-Fluorouracil (5-FU)
500 mg/m\^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
Epirubicin
75 mg/m\^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.
Cyclophosphamide
500 mg/m\^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.
UT MD Anderson Cancer Center, Houston
Collaborators (1)
GlaxoSmithKline
INDUSTRY
M.D. Anderson Cancer Center
OTHER