VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer

Inclusion Criteria: * Histological or cytological diagnosis of breast cancer * Stage IV disease * None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted) * Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+) * ECOG Performance Status 0-2 * Age \>18 and \< 75 years * Left Ventricular Ejection Fraction (LVEF) \>50% * Life expectancy \>3 months * Signed informed consent Exclusion Criteria: * Absence of measurable or evaluable disease * Life expectancy \< 3 months * ECOG performance status \> 2 * History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ). * Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease) * Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted) * Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 9 g/dl * Creatinine \> 1.5 x the upper normal limits * GOT and/or GPT \> 2.5 x the upper normal limits and/or Bilirubin \> 1.5 x the upper normal limits in absence of hepatic metastases * GOT and/or GPT \> 5 x the upper normal limits and/or Bilirubin \> 3 x the upper normal limits in presence of hepatic metastases * Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia * Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * Male gender * Pregnant or lactating women * Refusal or incapacity to provide informed consent * Inability to comply with follow up