Abstract Introduction: Pre-operative axillary staging is now widely accepted as a prerequisite in surgical management of the axilla for patients newly diagnosed with early breast cancer. For those patients having breast tumour excision who are found to have nodal involvement, axillary clearance can be performed at the same time without prior sentinel node biopsy. Ultrasound (US) alone has low sensitivity, but can be used to direct needle biopsy. We assessed and compared the sensitivity and specificity of US-guided core biopsies (USCB) and US-guided fine needle cytology (USFNAC) used in our unit. Patients and methods: A retrospective and prospective data collection was performed between November 2007 and May 2010 on all newly diagnosed breast cancer patients in our unit since the introduction of routine pre-operative axillary US. Patients whose nodes looked benign or normal on US were offered sentinel node biopsy (SNB). Patients found to have suspicious nodes were offered USFNAC or USCB, according to the individual preference of the radiologists. Patients with positive cytology or histology underwent axillary node clearances (ANC), those with benign cytology or histology were offered SNB. The final histology results were reviewed and correlated to their pre-operative histology or cytology. Results: Of 559 Axillary ultrasound scans performed in our department between November 2007 and May 2010, 229 patients had pre-operative US scans of the axilla for newly diagnosed, clinically node-negative breast cancer. Of these 46 had USFNAC, 44 had USCB and 139 had normal/benign US. The USFNAC and USCB groups had similar proportions of positive results on postoperative histology, namely 70% and 79% respectively, allowing direct comparisons to be made. Of the 46 USFNAC patients, 17 (37%) had positive cytology (all confirmed by axillary clearance final histology). The 29 USFNAC patients with negative cytology had 15 (52%) with positive histology on sentinel node biopsy. The sensitivity of USFNAC was 53% and the specificity 100%. Of the 44 USCB patients, 26 (59%) were positive (all confirmed by axillary clearance final histology). Of the 18 USCB-negative patients, 7 (39%) were found to be positive on axillary clearance. The sensitivity of USCB was 79% and the specificity 100%. Of the 139 patients with normal US, 42 (30%) were found to be positive on sentinel node biopsies. For US alone, sensitivity was 61% and specificity was 80%. Conclusion: US staging of the axilla is superior to clinical staging. However, there is still a high incidence of false negative results, making US a crude way of assessing the axilla and confirming the necessity for sentinel node biopsy in US-negative axillae. For patients with axillae that are indeterminate on US, our data supports routine use of ultrasound core biopsy (USCB) over Ultrasound fine needle aspiration cytology (USFNAC) for preoperative staging of the axilla, where technically feasible. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-01-19.