Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 1, 2009

Primary Completion Date

October 1, 2013

Study Completion Date

October 1, 2013

Conditions
Breast Neoplasms
Interventions
DRUG

Trastuzumab

Load: 4mg/kg-maintain:2mg/kg/week

DRUG

BIBW 2992

Increased dose cohorts from low dose to MTD

Trial Locations (5)

Unknown

1200.68.44001 Boehringer Ingelheim Investigational Site, Brighton

1200.68.44003 Boehringer Ingelheim Investigational Site, Cambridge

1200.68.44005 Boehringer Ingelheim Investigational Site, Guildford

1200.68.44004 Boehringer Ingelheim Investigational Site, Newcastle upon Tyne

1200.68.44002 Boehringer Ingelheim Investigational Site, Truro

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00950742 - Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer. | Biotech Hunter | Biotech Hunter