OBJECTIVE: This study aimed to evaluate the predictive value of implementing machine learning models based on ultrasound radiomics and clinicopathological features in the survival analysis of triple-negative breast cancer (TNBC) patients. METHODS AND MATERIALS: All patients, including retrospective cohort (training cohort, n = 306
internal validation cohort, n = 77) and prospective external validation cohort (n = 82), were diagnosed as locoregional TNBC and underwent pre-intervention sonographic evaluation in this multi-center study. A thorough chart review was conducted for each patient to collect clinicopathological and sonographic features, and ultrasound radiomics features were obtained by PyRadiomics. Deep learning algorithms were utilized to delineate ROIs on ultrasound images. Radiomics analysis pipeline modules were developed for analyzing features. Radiomic scores, clinical scores, and combined nomograms were analyzed to predict 2-year, 3-year, and 5-year overall survival (OS) and disease-free survival (DFS). Receiver operating characteristic (ROC) curves, calibration curves, and decision curves were used to evaluate the prediction performance. FINDINGS: Both clinical and radiomic scores showed good performance for overall survival and disease-free survival prediction in internal (median AUC of 0.82 and 0.72 respectively) and external validation (median AUC of 0.70 and 0.74 respectively). The combined nomograms had AUCs of 0.80-0.93 and 0.73-0.89 in the internal and external validation, which had best predictive performance in all tasks (p <
0.05), especially for 5-year OS (p <
0.01). For the overall evaluation of six tasks, combined models obtained better performance than clinical and radiomic scores [AUCs of 0.83 (0.73,0.93), 0.81 (0.72,0.93), and 0.70 (0.61,0.85) respectively]. INTERPRETATION: The combined nomograms based on pre-intervention ultrasound radiomics and clinicopathological features demonstrated exemplary performance in survival analysis. The new models may allow us to non-invasively classify TNBC patients with various disease outcome.