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Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery

NCT07762924 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-08-13

No results posted yet for this study

Summary

This is a single-center, prospective phase II clinical study designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in young patients with low-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women younger than 40 years with low- or intermediate-grade DCIS, tumor size ≤1 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and unifocal screen-detected disease. Patients in the radiotherapy omission cohort will undergo close surveillance after surgery, with endocrine therapy permitted according to physician discretion. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).

Conditions

  • Ductal Carcinoma In Situ, DCIS

Interventions

OTHER

Observation

No postoperative radiotherapy will be administered. Patients will receive close surveillance after surgery.

DRUG

Endocrine Therapy (Optional)

Adjuvant endocrine therapy may be administered according to physician discretion and patient preference.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2032-02-29
Completion
2037-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762924 on ClinicalTrials.gov