Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

Inclusion Criteria:

• Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.
• No previous chemotherapy treatment for metastatic disease.
• No previous anthracycline treatment except as adjuvant therapy at least one year before.
• Age 19-75 years old
• Presence of measurable disease
• Performance status 0-2 (WHO)
• Adequate cardiac function (LVEF >50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina.
• Adequate bone marrow(absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3), liver (bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal) and renal function (creatinine <2mg/dl).
• No previous radiotherapy to more than 25% of marrow-containing bones.
• Written informed consent

Exclusion Criteria:

• Active brain metastases.
• Psychiatric illness or social situation that would preclude study compliance
• Other concurrent uncontrolled illness.
• Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer.
• Positive pregnancy for premenopausal women.
• Concurrent antineoplastic treatment e.g. hormonal therapy