This multicenter, cluster randomized trial will evaluate whether community-based breast ultrasound screening improves the early detection of breast cancer in women aged 65 to 80 years, compared with routine health management. Approximately 80,000 women in Jiangsu Province, China, will be enrolled and followed for breast cancer outcomes.
Female participants aged 65-80 years.
Local residents living in participating communities for ≥6 months.
Signed informed consent and willingness to participate.
History of breast cancer or previous breast cancer treatment.
Breast cancer screening within the past 2 years.
Severe comorbid conditions that may affect study participation or follow-up.
Acute breast disease or conditions requiring immediate treatment.
Parallel
Standardized Breast Ultrasound Screening
Diagnostic testOne standardized breast ultrasound examination performed and interpreted by a qualified physician, with further clinical evaluation of abnormal findings as appropriate.
Absolute difference in early-stage breast cancer diagnosis rate
The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II.
Overall breast cancer detection rate
The proportion of participants diagnosed with breast cancer in each group during follow-up.
Late-stage breast cancer diagnosis rate
The proportion of participants diagnosed with stage III or IV breast cancer in each group.
Breast biopsy rate
The proportion of participants undergoing a breast biopsy in each group during follow-up.
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