2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions;
3. Tumor size ≤2.5 cm on final pathology;
4. Negative surgical margins ≥3 mm, including margins obtained after re-excision;
5. Estrogen receptor-positive disease (ER ≥10%) with planned endocrine therapy using tamoxifen;
6. Unifocal lesion;
7. Absence of comedo necrosis;
8. Screen-detected disease without bloody nipple discharge or palpable mass;
9. Clinically node-negative disease;
10. Patients randomized to the radiotherapy arm must initiate radiotherapy within 3 months after surgery;
11. Central pathology review by the participating institution required;
12. Ability to understand and willingness to sign written informed consent.
You may not be if
1. Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory);
2. Contraindications to radiotherapy, including active connective tissue disease;
3. Active infection requiring systemic treatment;
4. Bilateral breast cancer or prior contralateral breast cancer;
5. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders;
6. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ;
7. Prior thoracic radiotherapy;
8. Pregnant or breastfeeding patients;
9. Estimated life expectancy ≤5 years;
10. Poor compliance or inability to adhere to study follow-up requirements.
Clareo Health | Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery