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Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery
Sponsor: Fudan University
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).
Official title: A Single-Center Prospective Phase II Study Evaluating the Safety of Omission of Adjuvant Radiotherapy in Young Patients With Low-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
Key Details
Gender
FEMALE
Age Range
Any - 40 Years
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2026-09-01
Completion Date
2037-02
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Observation
No postoperative radiotherapy will be administered. Patients will receive close surveillance after surgery.
Endocrine Therapy (Optional)
Adjuvant endocrine therapy may be administered according to physician discretion and patient preference.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China