Background & Objectives: Breast cancer is the most common cancer in women worldwide, disproportionately affecting low- and-middle income countries (LMICs). 52.6% of new breast cancer cases occur in LMICs, and this is expected to grow to 70% by year 2020. Two-thirds of the estimated 15,000,000 healthy-life years lost annually to breast cancer globally are from LMICs. The 5-year survival rate is 40-60% in most LMICs as compared to 80-90% in High Income Countries (HICs). Low-cost, user-friendly technology can help equip minimally trained community health workers to administer standardized breast exams without any special infrastructure, with the goal to down-stage breast cancer.

Methods: IRB cleared prospective trial enrolled women as part of a community screening program or women seeking medical advice for breast related symptoms. Consenting women above age 30 were eligible to enroll. Subjects received an iBreastExam evaluation and a Clinical Breast Examination (CBE), each by a different health-worker, blinded to the other test. Subjects positive on iBE and/or CBE, received follow-up diagnostic imaging (mammogram for women above age 40 years or breast ultrasound for women age 40 years or younger). Standard of truth was established as a positive mammogram BIRADS 3-6 or a positive ultrasound as BIRADS 3-6. To assess accuracy of iBE and CBE to detect lesions, the sensitivity and specificity were calculated compared to diagnostic imaging. For the purposes of analysis, each breast was considered as an independent result. Instead of detection of cancer, standardized diagnostic imaging modalities (mammogram and ultrasound) were used as comparators because the palpation device was evaluated as a tool in LMIC settings to enable early detection of suspicious breast lumps requiring clinical follow-up.

Results: 1,200 women (2,400 breasts) with median age of 43 years were examined under this study with both, iBE and CBE. From 2,400 breasts, 96 were identified by iBreastExam, CBE or both to have at least one breast lesion. An additional 63 women (126 breasts) enrolled in the study due to a breast related symptom and were examined with iBE, CBE and age-appropriate diagnostic imaging. Combining both groups, 222 breasts were examined with age-appropriate diagnostic imaging. Compared to diagnostic imaging, the sensitivity, specificity, Negative Predictive Value and Positive Predictive Value of iBE is 86%, 91%, 98%, 57%, respectively. Compared to diagnostic imaging, the sensitivity, specificity, Negative Predictive Value and Positive Predictive Value of CBE is 63%, 82%, 94%, 32%, respectively.

Conclusions: Compared to Clinical Breast Exam, iBreastExam demonstrated significantly (23%) higher sensitivity and moderately (9%) higher specificity to detect breast lesions. Given that iBE requires minimal training and provides objective breast examination with digital documentation; better performance than clinical exam highlights the tools’ utility as a triaging tool by identifying women in need for follow-up diagnostics. iBreastExam may enable community health worker led triaging to detect clinically relevant breast lesions in LMIC settings.

Citation Format: Suma Nair, Thejas Kathrikolly, PU Prakash Saxena. Clinical efficacy evaluation of a novel palpation imaging device for early detection of breast cancer in the developing world [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-01-01.