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RECRUITING
NCT07762885
PHASE3

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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).

Official title: A Prospective, Multicenter, Randomized Phase III Non-Inferiority Trial Evaluating Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk ER-Positive HER2-Negative Ductal Carcinoma In Situ Following Breast-Conserving Surgery

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

636

Start Date

2026-07-01

Completion Date

2036-06

Last Updated

2026-08-13

Healthy Volunteers

No

Interventions

RADIATION

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.

DRUG

tamoxifen

Adjuvant endocrine therapy with tamoxifen according to institutional practice.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China