Conditions: Breast Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

Brief summary:
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®

Detailed description:

Arms:
arm 1: Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.

Interventions: intervention 1: Trastuzumab intervention 2: BIBW 2992
Intervention descriptions: intervention 1: Load: 4mg/kg-maintain:2mg/kg/week intervention 2: Increased dose cohorts from low dose to MTD

Protocol document: