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

RecruitingPhase 2Ages any - 40 YearsFemaleFudan University
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In plain words

What the trial is, and whether it could suit you

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).

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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 ≤1 cm on final pathology; 4. Negative surgical margins ≥3 mm, including margins obtained after re-excision; 5. Unifocal lesion; 6. Absence of comedo necrosis; 7. Screen-detected disease without bloody nipple discharge or palpable mass; 8. Clinically node-negative disease; 9. Central pathology review by the participating institution required; 10. Ability to understand and willingness to sign written informed consent. Exclusion Criteria: 1. Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory); 2. Bilateral breast cancer or prior contralateral breast cancer; 3. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders; 4. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ; 5. Pregnant or breastfeeding patients; 6. Estimated life expectancy ≤5 years; 7. Poor compliance or inability to adhere to study follow-up requirements.
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What it tests

  • Observation
  • Endocrine Therapy (Optional)
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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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