Breast cancer screening based on clinical breast examination performed by community health workers: study protocol for a randomized clinical trial. ITABERAÍ Project / ReBEC n° RBR-39vm2nd

OBJECTIVE: The ITABERAÍ project evaluates whether breast cancer screening based on clinical breast examination (CBE) performed by community health workers (CHWs) can reduce advanced breast cancer and mortality. METHODS: This prospective, phase III, cluster-randomized controlled trial includes women aged ≥40 years using Brazil's public health system. Primary healthcare units and their Family Health Teams were randomized to a control group (CG) or intervention grop (IG). CHWs in the CG received standard breast cancer screening training. Female CHWs in the IG received standard training plus additional theoretical and practical training in CBE. Data collection includes sociodemographic characteristics, lifestyle factors, medical history, and CBE findings. The sample size was calculated to detect a 10% reduction in advanced cases and a 20% reduction in mortality, with 2104 per group. A pilot test from August to December 2022 validated CRFs, workflows, and the integrated data-collection system. Ethics approval was obtained (CAAE 56916522.8.0000.5078). TRIAL STATUS: The trial was initiated in January 2023. By March 2026, 4036 women had been randomized, 2056 (98%) to the control group and 1980 (94%) to the intervention group. The study runs for 16 years. Recruitment is intended to be completed in December 2026. TRIAL REGISTRATION: RBR-39vm2nd. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (ReBEC) RBR-39vm2nd; registered on 12 March 2023. https://ensaiosclinicos.gov.br/rg/RBR-39vm2nd.