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

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 t

Trial Details

NCT ID
NCT07762924
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • Observation
  • Endocrine Therapy (Optional)
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 ≤1 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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