A clinical trial to test Vinorelbine + BIBW 2992 (type of anti cancer treatment) vs Vinorelbine + Herceptin (type of anti cancer treatment) in breast cancer Patients After Failing Herceptin Treatment

INTERVENTION: Intervention1: BIBW 2992: once daily combined with weekly intravenous infusion of vinorelbine Control Intervention1: Trastuzumab: 2mg/kg intravenously every week combined with weekly intravenous infusion of vinorelbine CONDITION: Metastatic Breast Carcinoma PRIMARY OUTCOME: The primary endpoint of this study is progression‐free survival, defined as the time from the date of randomisation to the date of disease progression, or to the date of death if a patient died earlier‐‐‐‐‐‐Timepoint: date of randomisation to the date of disease progression SECONDARY OUTCOME: ‐Overall survivalbest ; ‐RECIST assessment and safety; ‐Tumour shrinkage; ‐Maintenance of body weight and ECOG; performance status; ‐Incidence of brain metastases; ‐Health‐related quality of life; pharmacokinetics of BIBW 2992‐‐‐‐‐‐Timepoint: Till patient is alive INCLUSION CRITERIA: ‐Histologically confirmed diagnosis of HER2‐overexpression breast cancer ‐Stage IV metastatic disease ‐Must have progressed on one prior trastuzumab treatment ‐no more than one prior trastuzumab based therapy regimen (either adjuvant or first‐line) ‐Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first‐line treatment of metastatic breast cancer ‐Must have (archived) tumour tissue sample available for central re‐assessment of HER2‐status ‐At least one measurable lesion according to RECIST 1.1. ‐ECOG score of 0 or 1 .