Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

Inclusion Criteria

• •Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
• •Age 18-75 years
• •HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
• •Previous therapies had to include, regimens containing an anthracycline and a taxane
• •Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
• •Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
• •Performance status (WHO) 0-2
• •Adequate liver (serum bilirubin \<1.5 times the upper normal limit; AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the upper normal limit); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
• •No radiation of measurable disease (except brain metastases)
• •No progressive brain metastases according to clinical or radiological criteria
• •No brain metastases without prior radiation therapy
• •Written informed consent