Comparison of iBreastExam with clinical breast examination for early detection of breast cancerin community outreach clinics in Pune, India

Clinical breast examination (CBE) is the only feasible option for the low- and middle-income countries that have the rising burden of breast cancers but lack adequate infrastructure and human resources for organised mammography screening programmes. However, CBE is a subjective test and this warrants evaluation of alternatives to CBE. We conducted a cross-sectional study to evaluate the agreement between iBreastExam (iBE) and CBE for early detection of breast cancers. Women aged 40 to 69 years were screened at community outreach clinics after obtaining a written informed consent. Women were screened with CBE first followed by iBE by two independent trained healthcare providers. Those who were positive on either were referred to an expert breast surgeon masked to the screening test results. If the expert breast surgeon detected a lump, mammography and/or USG and biopsy were advised. Of the 10,004 women consented, CBE and iBE both were performed on 9994 women. Screen positivity by either test was 1.5% (151/9994). CBE and iBE both were positive in 97/9994 (0.97%) women. The crude agreement between CBE and iBE was 99.5% (K = 0.78, SE 0.029, 95% CI 0.72–0.84). Among the 9994 women screened, 14 (0.14%) breast cancers were detected. Three breast cancers were diagnosed among asymptomatic women who tested positive by CBE but negative by iBE. Refinement of iBE to improve its sensitivity and additional research studies are needed before deploying this device for breast cancer screening in any program.