NCT07385365

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

A Phase Ⅲ Randomized Clinical Study and Real World Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,142 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2032-12-31
• Completion: 2042-12-31
• First posted: 2026-02-04
• Last updated: 2026-02-11

Locations

1 site across 1 country: China