Clinical Trial

Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery

Recruiting Phase 3
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Summary
This is a prospective, multicenter, randomized, open-label, phase III non-inferiority trial designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in patients with low- and intermediate-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women aged ≥40 years with ER-positive, low- or intermediate-grade DCIS, tumor size ≤2.5 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and screen-detected unifocal disease. Patients will be randomized to postoperative observation alone or adjuvant radiotherapy. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).
Trial Details
NCT Number NCT07762885
Lead Sponsor Fudan University
Conditions Ductal Carcinoma In Situ, DCIS
Enrollment 636 participants
Start Date 2026-07-01
Primary Completion 2031-06 (estimated)
Study Completion 2036-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-13