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

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 radiothera

Trial Details

NCT ID
NCT07762885
Phase
PHASE3
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Adjuvant Radiotherapy
  • tamoxifen
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Female patients aged ≥40 years；
  • Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identifie…
  • Tumor size ≤2.5 cm on final pathology；
  • Negative surgical margins ≥3 mm, including margins obtained after re-excision；

For full eligibility, visit ClinicalTrials.gov.

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