140
Participants
Start Date
October 31, 2011
Primary Completion Date
November 30, 2013
Study Completion Date
April 30, 2014
BIBF + Paclitaxel
"Priming Period:~Oral BIBF 1120 will be administered during 2 weeks at the dose determined during the phase-I part that can be combined safely with weekly paclitaxel, on a continuous schedule for 14 days.~One week washout is planned before starting the treatment phase.~Treatment Phase:~Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 + BIBF 1120 recommended dose bid po days 1-21 q 21 days. (BIBF 1120 morning dose is skipped on the paclitaxel administration days)."
Paclitaxel
Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 q 21 days. A total of 4 cycles will be administered in both arms.
MD Anderson Cancer Centre Madrid, Madrid
Hospital Universitario de Fuenlabrada, Fuenlabrada
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat
Hospital Universitario de Fuenlabrada
OTHER
M.D. Anderson Cancer Center
OTHER
Hospital Universitari de Bellvitge
OTHER
Grupo Espanol de Investigacion del Cancer de Mama
OTHER
Centro Nacional de Investigaciones Oncologicas CARLOS III
OTHER