About this trial
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).
Eligibility criteria
Qualifiers
Female patients aged <40 years;
Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions;
Tumor size ≤1 cm on final pathology;
Negative surgical margins ≥3 mm, including margins obtained after re-excision;
Disqualifiers
Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory);
Bilateral breast cancer or prior contralateral breast cancer;
Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders;
History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ;
Trial design
Treatments tested in this trial
- Observation
- Endocrine Therapy (Optional)