Inclusion Criteria:

- HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods:
Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+
it is needed a positive FISH test

- Female < 70yrs

- Histologically or cytologically proven breast cancer.

- Metastatic or locally advanced breast cancer (clinical stage: III-IV)

- Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by
echocardiography with FEVS ≥50%

- Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total
dose ≤450 mg/m2

Exclusion Criteria:

- History of cardiopathy

- Severe hepatic and renal diseases

- Brain metastases as the only parameter of disease

- Contraindication to the use of corticosteroids as premedication

- Acute infectious diseases

- Insulin-dependent diabetes

- History of other cancers except for adequately treated basal cell skin cancer or in
situ carcinoma of the cervix

- Concurrent treatment with any other cancer therapy