Clinical Research Directory
Browse clinical research sites, groups, and studies.
Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
Sponsor: Fudan University
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
Conditions
Interventions
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.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China