Omission of Radiotherapy After Breast-Conserving Surgery for Certain DCIS Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase III, multicenter, randomized, open-label trial comparing post-surgery observation to adjuvant radiotherapy in women with ER-positive, low- or intermediate-grade DCIS that is small, has clear margins, and lacks comedo necrosis. Participants are ≥40 years old and must meet detailed pathology and clinical criteria, including unifocal disease and screen-detected cancer. The primary endpoint is the rate of ipsilateral breast tumor recurrence at 5 years. Randomization assigns patients to observation or radiotherapy, with central pathology review confirming eligibility. Endocrine therapy with tamoxifen is allowed as per standard care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Xiaoli Yu
• Email: xiaoliyu@fudan.edu.cn
• Phone: +86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.