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Purpose: To establish a reliable machine learning model to predict malignancy in breast lesions identified by ultrasound (US) and optimize the negative predictive value to minimize unnecessary biopsies., Methods: We included clinical and ultrasonographic attributes from 1526 breast lesions classified as BI-RADS 3, 4a, 4b, 4c, 5, and 6 that underwent US-guided breast biopsy in four institutions. We selected the most informative attributes to train nine machine learning models, ensemble models and models with tuned threshold to make inferences about the diagnosis of BI-RADS 4a and 4b lesions (validation dataset). We tested the performance of the final model with 403 new suspicious lesions., Results: The most informative attributes were shape, margin, orientation and size of the lesions, the resistance index of the internal vessel, the age of the patient and the presence of a palpable lump. The highest mean negative predictive value (NPV) was achieved with the K-Nearest Neighbors algorithm (97.9%). Making ensembles did not improve the performance. Tuning the threshold did improve the performance of the models and we chose the algorithm XGBoost with the tuned threshold as the final one. The tested performance of the final model was: NPV 98.1%, false negative 1.9%, positive predictive value 77.1%, false positive 22.9%. Applying this final model, we would have missed 2 of the 231 malignant lesions of the test dataset (0.8%)., Conclusion: Machine learning can help physicians predict malignancy in suspicious breast lesions identified by the US. Our final model would be able to avoid 60.4% of the biopsies in benign lesions missing less than 1% of the cancer cases., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)