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

Background: This study presents the preliminary results of a randomized controlled trial (RCT) initiated in January 2006 in India to evaluate the effectiveness of clinical breast examination (CBE) in reducing breast cancer mortality as compared to a no‐screening control group reported significant downstaging in the intervention group. The present manuscript reports long‐term follow‐up outcomes. Methods: Women 30–69 years old from 133 intervention clusters and 141 control clusters were invited to participate. Women in the intervention arm underwent three rounds of CBE every 3 years. CBE‐positive women were reexamined by a physician, and triple‐assessment was performed on those confirmed to have abnormalities. All participants were followed through home visits and linkage with population‐based cancer registry. Results: Of the 55,843 eligible women in the intervention arm, 95.7% had CBE at least once and 11.5% were CBE‐positive. Breast cancers were diagnosed in 335 participants in the intervention group and 273 in the control group (N = 59,447). Age‐standardized incidence rate of early cancer was 30.4 of 100,000 in the intervention and 21.9 of 100,000 in the control group, with a rate ratio (RR) of 1.4 (95% confidence interval [CI], 1.1–1.8). The age‐standardized breast cancer mortality rates were 11.3 and 11.1 per 100,000 in intervention and control arms, respectively (RR, 1.1; 95% CI, 0.8–1.5) after 15 years. Five‐year breast cancer survival rates were 77.0% in the intervention and 71.2% in the control groups (overall p value =.043). Conclusions: Triennial CBE screening failed to demonstrate any mortality benefit despite achieving a shift toward earlier stage at detection and improved survival in the intervention arm. CBE is a valuable tool for diagnosis of breast cancer in symptomatic women especially in areas where mammography and/or breast cancer screening programs are not widely available. The authors demonstrated that an "early diagnosis" approach can be as effective as clinical breast examination screening in reducing breast cancer mortality. These observations have major policy implications. [ABSTRACT FROM AUTHOR]