Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

April 30, 2014

Conditions
Breast Cancer
Interventions
DRUG

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)."

DRUG

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.

Trial Locations (3)

28033

MD Anderson Cancer Centre Madrid, Madrid

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

All Listed Sponsors
collaborator

Hospital Universitario de Fuenlabrada

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Hospital Universitari de Bellvitge

OTHER

collaborator

Grupo Espanol de Investigacion del Cancer de Mama

OTHER

lead

Centro Nacional de Investigaciones Oncologicas CARLOS III

OTHER

NCT01484080 - Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates | Biotech Hunter | Biotech Hunter