Purpose:To evaluate the negative predictive value (NPV) of ultrasound (US) elastography for non-palpable Breast Imaging Reporting and Data System (BI-RADS) category 3 lesions on ultrasonography and to determine whether US elastography is helpful in reducing the number of BI-RADS category 3 lesions on ultrasonography.Methods:Two hundred seventy-six consecutive, non-palpable BI-RADS category 3 lesions in 256 women who underwent US elastography and US-guided core biopsy, and who had at least 12 months of follow-up data, comprised our study group. The BI-RADS final assessment category and elasticity score were prospectively and independently classified. The rate of malignancy and NPV according to the elasticity score were analysed. We also investigated whether there was a subset of BI-RADS category 3 lesions that were of benign histology but negative on elastography.Results:Of the 276 non-palpable BI-RADS category 3 lesions, three lesions (1.0%) were finally confirmed as ductal carcinomas in situ. No cancers were found in the remaining 273 lesions with benign biopsy histology at a mean follow-up of 39.4 months (range, 12 to 72 months). The NPV of a negative elasticity score (elasticity score of 1) was 99.3% (165 of 166). If BI-RADS category 3 lesions showing a negative elasticity score were downgraded to BI-RADS category 2, 60.4% (165 of 273) of them with benign histology could have been safely followed without biopsy with an increased malignancy rate from 1% (3 of 276) to 1.8% (2 of 110), which is not significantly higher (P=0.626).Conclusion:US elastography has the potential to reduce the number of BI-RADS category 3 lesions on ultrasonography.