Conditions: Breast Neoplasms Neoplasm Metastasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

Detailed description:

Arms:
arm 1: Afatinib monotherapy: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg. arm 2: Afatinib 40 mg per day, continuous treatment, in combination with vinorelbine Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course. arm 3: Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.

Interventions: intervention 1: Vinorelbine intervention 2: Investigator's choice of treatment intervention 3: afatinib intervention 4: afatinib
Intervention descriptions: intervention 1: Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course intervention 2: Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines. intervention 3: Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg. intervention 4: Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.

Protocol document: