29
Participants
Start Date
November 30, 2011
Primary Completion Date
January 28, 2015
Study Completion Date
January 28, 2015
U3-1287
U3-1287: 18 mg/kg administered intravenously once every three weeks
Trastuzumab
Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks
Paclitaxel
Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks
U3-1287
The maximum tolerated dose as determined in Phase 1b portion (between 9 mg/kg and 18 mg/kg) administered intravenously once every three weeks
Trastuzumab
Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks
Paclitaxel
Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks
Placebo
Placebo: Dose corresponding to U3-1287 administered intravenously once every three weeks
Unidad de Investigación FP Clinical Pharma en Centro Medico Integral Fitz Roy, Acevedo
Instituto de Tereplas Oncologicas Providencia INTOP, Providencia
Hospital Clinico San Borja Arriaran, Santiago
Centro Medico San Roque, San Miguel
Hospital Britanico, Buenos Aires
Sanatorio de la Providencia, Buenos Aires
Instituto Damic - Fundacion Rusculleda, Córdoba
ISIS Centro Especializado, Santa Fe
Lead Sponsor
Daiichi Sankyo
INDUSTRY