Mono Efficacy of Capecitabine (MoniCa)

Study design: Prospective, open phase II trial Treatment: Capecitabine 2000 mg/m² orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study Primary objective To determine the time to disease progression in patients with HER2 negative metastatic breast cancer after 1st line monochemotherapy with capecitabine Secondary objectives 1. To determine the objective response rate 2. To determine the duration of response 3. To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks 4. To evaluate the safety and toxicity of capecitabine 5. To assess quality of life within 1 year after start of capecitabine treatment 6. To determine overall survival 7. To determine the objective response rate in male patients 8. To evaluate QoL the modified Brunner Score (Appendix 7 ) Tertiary objective To determine the DPD and Proteomics in serum