Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

• Performance status (WHO) 0-2
• Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
• HER-2 overexpression 2+ or 3+ using IHC or FISH +
• Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
• No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
• More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
• No prior first line chemotherapy for metastatic disease
• Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
• Paraffin block from the primary tumor available in the research lab
• Adequate bone marrow function (absolute neutrophil count > 1000/mm\^3, platelet count > 100000/mm\^3, hemoglobin > 9 gr/mm\^3)
• Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
• Adequate cardiac function (LVEF > 50%)
• Informed consent

Exclusion Criteria:

• Pregnant or nursing
• Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
• Positive pregnancy test
• Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
• Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
• History of allergic reaction attributed to docetaxel
• Psychiatric illness or social situation that would preclude study compliance
• Other concurrent uncontrolled illness.
• Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ