Abstract BackgroundLMICs face challenges in early breast cancer detection due to limited mammography availability, with average tumor sizes at diagnosis around 3.5 cm. The WHO Global Breast Cancer Initiative aims for 60% early-stage detection, necessitating effective triage tools. We developed and evaluated the Breast Clinical Reporting and Data System (BCRADS) to standardize clinical breast examination (CBE) in LMICs to improve early detection while reducing unnecessary referrals. MethodsA prospective observational study was conducted at a tertiary care breast clinic in India, enrolling 418 women with breast symptoms between Insert Dates. Cancer group: 240 biopsy-confirmed breast cancer patients. Benign group: 178 patients with benign breast conditions. Each patient underwent structured history and systematic CBE, with BCRADS scoring assigned as follows: BCRADS Scoring: History: - Age: 40 (0), 40-50 (1), 50 (2) - Family history: No (0), Yes (1) - Prior chest wall radiation: No (0), Yes (1) - BRCA carrier: No (0), Yes (2) Clinical Examination: - Asymmetry: Absent (0), Present (1) - Skin ulcer/PDO: Absent (0), Present (2) - Hard fixed lump: Mobile (0), Fixed (2) - Axillary lump: Absent (0), Present (2) Total score range: 0-15. Higher scores indicate greater suspicion for malignancy. Analysis: BCRADS scores were compared between groups. ROC curve analysis was performed to evaluate discriminative ability, with optimal cut-off identified via Youden’s index. Sensitivity, specificity, PPV, NPV, and accuracy at the cut-off were calculated. ResultsThe mean BCRADS score was significantly higher in the cancer group (8.2 ± 2.4) compared to the benign group (3.1 ± 1.9, p 0.001). ROC analysis showed AUC = 0.89 (95% CI: 0.86-0.92), indicating excellent discrimination. At the optimal cut-off of 6: - Sensitivity: 88% - Specificity: 79% - PPV: 85% - NPV: 83% - Accuracy: 84%ConclusionsThe BCRADS tool demonstrates high accuracy in predicting malignancy using standardized clinical assessment, enabling effective early detection triage in LMIC settings where mammography is limited. Integration of BCRADS into primary care workflows can reduce unnecessary referrals, prioritize imaging, and align with WHO goals of increasing early breast cancer detection. Future multicentric validation and integration with digital platforms for scale-up in LMICs are planned. Citation Format: S. Das, R. Agarwal, T. Mandal, A. Ali Mallick, R. Paul, D. Sarakar. Breast Clinical Reporting and Data System (BCRADS): A Pragmatic, Low-Cost Tool for Early Detection of Breast Cancer in LMICs abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS4-11-28.
Das et al. (Tue,) studied this question.