Mono Efficacy of Capecitabine (MoniCa)

Inclusion Criteria

• •1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
• •2. Histologically confirmed carcinoma of the breast.
• •3. Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
• •4. Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
• •5. The following previous systemic treatment are eligible:
• •adjuvant chemotherapy (except if capecitabine was included) adjuvant endocrine therapy palliative endocrine treatments treatment with bisphosphonates (adjuvant and/or palliative) treatment with immunotherapies (adjuvant and/or palliative)
• •6. Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 5).
• •7. At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease.
• •8. Complete radiology and tumor measurement work up within 4 weeks prior to registration.
• •9. Karnofsky performance status evaluation \> or = 60%
• •10. Age \>18 years
• •11. WBC \> or = 3000 cells/microl, platelet count \> or = 100,000 cells/microl.
• •12. Bilirubin \< or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase \< 2.5x ULN or \<5x ULN for patients with liver metastases.
• •13. Creatinine \< or = 1,25 x upper normal value or creatinin-clearance \> 50 ml/min (according to Cockroft Gault).
• •14. If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study.
• •15. Female and male patients