Conditions: Breast Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.

Detailed description:

Arms:
arm 1: Patients receive afatinib monotherapy once daily until progression of their disease

Interventions: intervention 1: Afatinib once daily (OD) intervention 2: Vinorelbine Weekly
Intervention descriptions: intervention 1: Patient to receive afatinib monotherapy until progression of their disease intervention 2: Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy

Protocol document: