Adjuvant Radiotherapy: One of the following protocol-approved radiotherapy regimens may be delivered:
* Partial breast irradiation (PBI): 26 Gy in 5 fractions;
* Partial breast irradiation (PBI): 40.05 Gy in 15 fractions.
* Whole breast ultrahypofractionated radiotherapy: 26 Gy in 5 fractions;
* Moderate hypofractionated whole breast radiotherapy: 40.05 Gy in 15 fractions. Radiotherapy should start within 3 months after surgery.
tamoxifen: Adjuvant endocrine therapy with tamoxifen according to institutional practice.
Study summary
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).
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Ipsilateral Breast Tumor Recurrence (IBTR) — 5 years Defined as recurrence of invasive carcinoma or DCIS in the ipsilateral breast.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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