ObjectiveThis study aimed to explore the value of strain elastography (SE) and shear wave elastography (SWE) following the World Federation of Ultrasound in Medicine and Biology (WFUMB) guidelines and recommendations in the real world in distinguishing benign and malignant breast lesions and reducing biopsy of BI-RADS (Breast Imaging Reporting and Data System) 4a lesions. MethodsThis prospective study included 274 breast lesions. The elastography score (ES) by the Tsukuba score, the strain ratio (SR) for SE, and Emax for SWE of the lesion(A) and the regions(A') included the lesion and the margin (0.5-5 mm) surrounding the lesion were measured. The sensitivity, specificity, and AUC were calculated and compared by the cutoff values recommended by WFUMB guidelines. ResultsWhen scores of 1 to 3 were classified as probably benign by WFUMB recommendation, the ES was significantly higher in malignant lesions compared to benign lesions (p < 0.05) in all lesions. For the cohort by size >20 mm, the sensitivity was 100%, and the specificity was 45.5%. ES had the highest AUC: 0.79(95% CI 0.72-0.86) with a sensitivity of 96.2%, and a specificity of 61.8% for the cohort by size <= 20 mm. For the Emax-A'-S2.5mm, when the high stiffness would be considered with Emax above 80 kPa in SWE, the malignant lesions were diagnosed with a sensitivity of 95.8%, a specificity of 43.3% for all lesions, a sensitivity of 88.5% for lesions with size <= 20 mm, and sensitivity of 100.0% for lesions with size >20 mm. In 84 lesions of BI-RADS category 4a, if category 4a lesions with ES of 1-3 points or Emax-A'-S2.5 less than 80 kPa could be downgraded to category 3, 52 (61.9%) lesions could be no biopsy, including two malignancies. If category 4a lesions with ES of 1-3 points and Emax-A'-S2.5 less than 80kPa could be downgraded to category 3, 23 (27.4%) lesions could be no biopsy, with no malignancy. ConclusionsThe elastography score for SE and Emax-A' for SWE after our modification were beneficial in the diagnosis of breast cancer. The combination of SWE and SE could effectively reduce the biopsy rate of BI-RADS category 4a lesions.