Trastuzumab and Vinorelbine in Advanced Breast Cancer

Inclusion Criteria: * Histologically or cytologically confirmed metastatic invasive mammary carcinoma. The primary cancer must be HER2 negative by fluorescence in situ hybridization and/or immunohistochemistry. * Patients must have CTCs with HER2 amplification by FISH. * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques of as 10mm or greater with spiral CT scan. * Study participants must have either archival primary tumor or metastatic tumor tissue available to allow analysis to confirm their HER2 status. * Patients must have received at least 1 prior chemotherapy regimen for metastatic breast cancer or evidence of disease progression within 6 months of completing adjuvant chemotherapy. Patients can receive any number of biological or hormonal regimens and remain eligible. * 18 years of age or older * Life expectancy of greater than 3 months * ECOG Performance Status of 0, 1 or 2 * Normal organ and marrow function as outlined in the protocol * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: * Participants must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, and may not have any pre-existing treatment-related toxicities in excess of grade 2 * Participants may not be receiving any other invest…