Clinical Trial

Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery

Recruiting Phase 2
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Summary
This is a single-center, prospective phase II clinical study designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in young patients with low-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women younger than 40 years with low- or intermediate-grade DCIS, tumor size ≤1 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and unifocal screen-detected disease. Patients in the radiotherapy omission cohort will undergo close surveillance after surgery, with endocrine therapy permitted according to physician discretion. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).
Trial Details
NCT Number NCT07762924
Lead Sponsor Fudan University
Conditions Ductal Carcinoma In Situ, DCIS
Enrollment 234 participants
Start Date 2026-09-01
Primary Completion 2032-02 (estimated)
Study Completion 2037-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-13