Lead Sponsor

National Cancer Institute, Naples

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

•Histologically or cytologically confirmed breast cancer
•Stage IV
•No prior or not more than one prior chemotherapy for metastatic disease
•Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method)
•Performance status 0-2 (ECOG)

•Absence of measurable disease
•Life expectancy \< 3 months
•Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
•Previous treatment with trastuzumab or vinorelbine
•Neutrophils \< 1500/mm3 or platelets \< 100000/mm3 or haemoglobin \< 8 g/dl
•Creatinine \> 1.5 x the value of the upper normal limit
•GOT and/or GPT \> 2.5 x the value of the upper normal limit and/or bilirubin \> 1.5 x the value of the upper normal limit in the absence of liver metastases
•GOT and/or GPT \> 5 x the value of the upper normal limit and/or bilirubin \> 3 x the value of the upper normal limit in the presence of liver metastases
•Left ventricular ejection fraction \< 50% (measured by ultrasound or MUGA angiography)
•Concomitant conditions that contraindicate the use of the drugs in the protocol
•Male gender
•Pregnancy or lactation·
•Incapacity or refusal to provide informed consent
•Inability to comply with followup

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