Abstract Purpose The aim of this study was to determine the indications, accuracy and complications of vacuum-as- sisted breast biopsy (VABB) performed using ultr- asonographic (US) guidance for non-palpable lesions. Materials and methods This was a prospective study in which results from consecutive US-guided VABB performed between January 1999 and April 2003 were subsequently compared to those from excisional biopsy or to long-term follow-up imaging. Results Four hundred and six lesions were submitted to VABB procedures. Out of those, 78.9% were benign, 18.8% were malignant, 1.7% was lobular neoplasia, and 0.4% was atypical duct hyperplasia. Underestimation occurred in 2.6% of the cases and false negative results in 0.6%. Sensitivity to VABB was 97%, specificity went up to 100%, negative predictive value was 99%, positive predictive value was 100%, and accuracy was 99%. Complications occurred in 9% of the patients. Conclusion US-guided VABB is an accurate and safe procedure. The main indication is the non-palpable suspicious breast lesions (category 4). This new tech- nique could be a good alternative for percutaneous and surgery biopsy. Keywords Breast Breast biopsy Ultrasound Vacuum-assisted breast biopsy Mammotome Introduction The widespread use of mammographic screening has led to increasing detection of early breast cancer with a reduction in mortality [1, 2]. At the same time, the diffusion of this method has increased the need for tissue diagnosis of the abnormalities found. Every year, approximately one million women undergo surgical procedures that aim to establish the nature of an abnormality found on mammography [3–6]. Therefore, it is essential to find a safe and accurate procedure in order to make the definitive diagnosis and avoid unnecessary surgical procedures. Percutaneous image-guided breast biopsy is an alternative to surgical biopsy due to histological assessment of breast lesions [1, 5]. For many years, we have been dependent on fine-needle aspiration cytol- ogy (FNAC) and on core-automated biopsy (CB) [1, E. Cassano M. Pizzamiglio F. Abbate Breast Imaging Unit, Department of Radiology, European Institute of Oncology, Milan, Italy L. A. B. D. Urban (&) Radiology, Hospital de Clinicas, Curitiba, Parana, Brazil e-mail: lineiurban@hotmail.com P. Maisonneuve Epidemiology Unit, Department of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy G. Renne G. Viale Department of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy G. Viale M. Bellomi School of Medicine, University of Milan, Milan, Italy M. Bellomi Department of Radiology, European Institute of Oncology, Milan, Italy Breast Cancer Res Treat (2007) 102:103–110 DOI 10.1007/s10549-006-9305-x 123 EPIDEMIOLOGY Ultrasound-guided vacuum-assisted core breast biopsy: experience with 406 cases Enrico Cassano Linei A. B. D. Urban Maria Pizzamiglio Francesca Abbate Patrick Maisonneuve Giuseppe Renne Giuseppe Viale Massimo Bellomi Received: 26 December 2005 / Accepted: 13 June 2006 / Published online: 13 July 2006 Ó Springer Science+Business Media B.V. 2006