Inclusion Criteria:

- pathologic diagnosis breast cancer

- HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1
measurable lesion as per RECIST criteria

- Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count
>100.000/mm3, hemoglobin >10gr/mm3)

- Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times
upper limit of normal) and renal function (creatinine <1.5mg/dl)

- Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of
significant heart disease

- age from 18 to 70y

- Karnofsky performance score ≥ 60

- Life expectancy of greater than 3 months

- Negative HCG pregnancy test for premenopausal women of reproductive capacity and for
women less than 12 months after the menopause.

- signed ICF

Exclusion Criteria:

- prior exposure vinorelbine for breast cancer

- prior exposure trastuzumab for breast cancer

- Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment

- use of any other investigational agents within the last 4 weeks before enrollment

- symptomatic, central nervous system metastases

- Hypersensitivity to trial medications

- breastfeeding or pregnant