Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients

Inclusion Criteria: * Written informed consent. * Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks. * Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin. * Node negative patients with tumour size \> 2 cm. * Positive axillary lymph nodes defined as at least 1 out of 6 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: pN1a (Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm), pN2a (Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2 mm)), pN3a (Metastases in 10 or more axillary lymph nodes \[at least one tumor deposit greater than 2 mm\]; or metastases to the infraclavicular \[level III axillary lymph\] nodes). * Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy. * Patients must not present evidence of metastatic disease. * Negative status of HER2 in primary tumour, known be…