🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07762885
Recruiting Phase 3

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

NCT07762885 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 3
Started
2026-07-01
Last updated
2026-08-13

Condition(s) studied

Ductal Carcinoma In Situ, DCIS

Investigational drug(s) / intervention(s)

Adjuvant Radiotherapytamoxifen →

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)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai China Recruiting

More Fudan University trials in China

Other trials for the same condition

Official registry record

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.

View NCT07762885 on ClinicalTrials.gov ↗ ← All trials in China