HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

Inclusion Criteria: * Histologically or cytologically confirmed breast cancer * Stage IV * No prior or not more than one prior chemotherapy for metastatic disease * Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method) * Performance status 0-2 (ECOG) Exclusion Criteria: * Absence of measurable disease * Life expectancy \< 3 months * Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated * Previous treatment with trastuzumab or vinorelbine * Neutrophils \< 1500/mm3 or platelets \< 100000/mm3 or haemoglobin \< 8 g/dl * Creatinine \> 1.5 x the value of the upper normal limit * GOT and/or GPT \> 2.5 x the value of the upper normal limit and/or bilirubin \> 1.5 x the value of the upper normal limit in the absence of liver metastases * GOT and/or GPT \> 5 x the value of the upper normal limit and/or bilirubin \> 3 x the value of the upper normal limit in the presence of liver metastases * Left ventricular ejection fraction \< 50% (measured by ultrasound or MUGA angiography) * Concomitant conditions that contraindicate the use of the drugs in the protocol * Male gender * Pregnancy or lactation· * Incapacity or refusal to provide informed consent * Inability to comply with followup