Conditions: Breast Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 508
Healthy volunteers: no

Brief summary:
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Detailed description:

Arms:
arm 1: patients receive weekly intravenous infusion of trastuzumab and vinorelbine arm 2: patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine

Interventions: intervention 1: BIBW 2992 intervention 2: trastuzumab intervention 3: vinorelbine intervention 4: vinorelbine
Intervention descriptions: intervention 1: patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management intervention 2: patients receive trastuzumab 2mg/kg intravenously every week intervention 3: patients receive vinorelbine 25mg/m² intravenously every week intervention 4: patients receive vinorelbine 25mg/m² intravenously every week

Protocol document: