Standardizing Clinical Breast Examination in Low-and Middle-Income Countries

In low- and middle-income countries, the landscape of breast cancer care is often defined by late-stage presentation. While clinicians in high-income countries often utilize mammography to detect sub-centimeter lesions, many LMICs face a "diagnostic window" where the median tumor size at presentation is 3.5 cm, and nearly 70% of patients are diagnosed at Stage III or IV. At this scale, the immediate hurdle is not just access to advanced imaging, but the lack of standardized, reliable clinical detection for palpable masses.

To address this gap, Soumen Das, MBBS, MS, FACS, founder and director of the Institute of Breast Diseases, Kolkata, and head of the Department of Surgical Oncology at Netaji Subhas Chandra Bose Cancer Hospital, developed the BC-RADS (Breast Clinical Reporting and Data System) study. Designed as a clinical counterpart to the imaging-based BI-RADS study, this system integrates patient history—including age, family history, and genetic risk—with standardized clinical examination findings like breast asymmetry and lump mobility.

The recent BCRADS-2 Implementation Study, a prospective trial conducted in 2024, sought to validate this model as a triage system for health care workers at all levels. With a reported sensitivity of 93.2% and specificity of 88.7%, the study demonstrates how a structured scoring system can bridge the gap between rural health workers and oncology specialists. In this interview with CancerNetwork®, Das explains the rationale behind BCRADS-2 and how standardizing clinical palpation serves as a critical first step toward downstaging breast cancer in low-resource settings.

Transcript:

If we look at the background of this study, we need to understand the natural history of breast cancer a little bit. Once a patient gets exposed to certain risk factors, then the patient develops [a] small cancer. Initially, one cell grows, then it rapidly proliferates into multiple cells. Now, to get a palpable lump in the breast, we need at least a 1 to 2 cm lump. Before that, it is not palpable by the hand of the patient or by the hand of the clinician. At this stage, we detect cancer with the help of mammography. If we look at the low- and middle-income countries, the median tumor size is 3.5 cm. Sometimes we get patients who have a tumor size of more than 5 cm. Most of the low- and middle-income countries have a delayed presentation. [A total of] 70% of our patients present either in stage III or in stage IV. That means the tumor is big. It has already metastasized to the axilla or other parts of the body.

Now, to solve this situation, if we can bring down the tumor size from 5 cm to 3 cm to 2 cm, then gradually we will be shifting to mammography. At this moment, we don’t require the installation of multiple mammographies across the country. That is not a cost-effective model. If we can bring down the tumor size to 2 cm, which can be palpated very well by the clinicians. Right now, our focus should be a good clinical palpation, a good clinical breast examination. Our aim of this study was to standardize the clinical breast examination, because in our previous study, that was a part of the BCRAD-1 study, we could see that there is a huge heterogeneity between the clinicians as well as the peripheral practitioners when it comes to a breast lump. As a doctor, I can say this lump is a malignant one. Another fellow, another colleague of mine, is saying this is not a malignant one. There was a heterogeneity. We wanted to standardize the [screening]. Now with that background, we started doing this, BCRADS-2 and BCRADS-1 preceding that study to standardize the clinical examination properly.

Reference

Das S, Paul R, Mandal TK, et al. Community-integrated early breast cancer detection in LMICs using BC-RADS: the breast clinical reporting and data system (BCRADS-2 Implementation Study). Accessed January 27, 2026.