Effectiveness of triennial screening with clinical breast examination: 14-years follow-up outcomes of randomized clinical trial in Trivandrum, India.

"CONFLICTS OF INTEREST Aparna Prakasan reports consulting fees from Regional Cancer Centre, Thiruvananthapuram. Rari Mony reports consulting fees from Regional Cancer Centre. The other authors made no disclosures."

"This study was supported in part by intramural funds from the International Agency for Research on Cancer (Lyon, France) to the Regional Cancer Center, Trivandrum, India. Where authors are identified as personnel of the International Agency for Research on Cancer/World Health Organization, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer/World Health Organization."

"The study was designed as a cluster RCT and the protocol was approved by the ethical review committees of IARC and RCC. The study is registered with ClinicalTrials.gov (identifier: NCT05301296). The CONSORT study design flowchart is shown in Figure . The study aimed to assess whether the incidence rate of advanced breast cancer could be reduced by 30% and if breast cancer mortality could be reduced by 20% by three rounds of CBE screening provided by trained health workers (HWs) at 3‐year intervals. The secondary objectives were assessment of CBE participation, CBE positivity, CBE false positivity, breast cancer detection by CBE, stage distribution of breast cancer, distribution of patients with primary tumor measuring ≤2 cm, and patients with no regional lymph node involvement. The randomization units constituted 274 electoral wards (clusters) of Trivandrum district, Kerala, India, that were randomly assigned to two groups of 141 and 133 clusters by a statistician at IARC. The groups were then randomly assigned to CBE screening (133 clusters) or to receive existing routine care (141 clusters). CBE or mammography screening is almost nonexistent in routine care in the study setting even now."