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

RecruitingPhase 3Ages 40 Years - anyFemaleFudan University
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In plain words

What the trial is, and whether it could suit you

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 radiotherapy. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Female patients aged ≥40 years; 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. Exclusion Criteria: 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.
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What it tests

  • Adjuvant Radiotherapy
  • tamoxifen
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Where

1 site
Fudan University Shanghai Cancer Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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