Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

January 28, 2015

Study Completion Date

January 28, 2015

Conditions
Metastatic Breast Cancer
Interventions
DRUG

U3-1287

U3-1287: 18 mg/kg administered intravenously once every three weeks

DRUG

Trastuzumab

Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks

DRUG

Paclitaxel

Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks

DRUG

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

DRUG

Trastuzumab

Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks

DRUG

Paclitaxel

Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks

DRUG

Placebo

Placebo: Dose corresponding to U3-1287 administered intravenously once every three weeks

Trial Locations (8)

Unknown

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

T4000LAK

Centro Medico San Roque, San Miguel

01280

Hospital Britanico, Buenos Aires

C1050AAK

Sanatorio de la Providencia, Buenos Aires

X5003DCE

Instituto Damic - Fundacion Rusculleda, Córdoba

S3000CVK

ISIS Centro Especializado, Santa Fe

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY