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A Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer

NCT07385365 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3142

Last updated 2026-02-11

No results posted yet for this study

Summary

The research hypothesis is that the tumor-free survival rate of intermediate-risk breast cancer patients exempted from RNI is not inferior to that of those receiving RNI. Patients with intermediate-risk breast cancer have a relatively low local-regional recurrence rate whether they undergo RNI or not.Patients were randomly assigned to the RNI group and the non-RNI group.After radiotherapy,the patients are followed the efficacy and toxicities of radiotherapy are evaluated.

Conditions

Interventions

RADIATION

Regional nodal Radiotherapy

postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region

RADIATION

Non-Regional nodal Radiotherapy

conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2032-12-31
Completion
2042-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07385365 on ClinicalTrials.gov