Sentinel lymph-node biopsy is an innovative method for axillary staging in breast cancer patients, based on the concept that information about the status of the entire lymphatic drainage from a tumour site could be obtained by identification and sampling of a "sentinel node". The aim of the study was to evaluate the impact of sentinel lymph-node biopsy in the management of patients with early invasive breast carcinoma. Three hundred and forty-one patients with primary invasive breast carcinoma measuring less than 2 cm (less than 3 cm from January 2001) and clinically negative axillary nodes were recruited into the study. Sentinel lymph-nodes were positive for metastases in 108/341 cases (31.7%). Micrometastases were found in 22 patients and isolated tumour cells in 1 case. The mean number of sentinel lymph-nodes removed was 1.8 per patient. The sentinel lymph-node was the only positive node in 57 of 108 patients (52.8%). The percentage of axillary recurrence in sentinel lymph-node-negative patients was 0%. The accuracy of sentinel lymph-node biopsy for axillary staging has been confirmed in many studies. Axillary recurrences after sentinel lymph-node biopsy range from 0 to 1.6% in many series, while axillary recurrence after axillary lymph-node dissection is about 0-3%. In our experience we observed no axillary recurrences in 233 patients with sentinel lymph-node biopsy alone, with a median follow-up of 33 months, confirming the accuracy of the procedure, and sentinel lymph-node-negative patients with sentinel lymph-node biopsy alone are no more at risk for axillary recurrences than those undergoing axillary lymph-node dissection.