NCT06375798

Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 620 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery.

Detailed description

This is a single-center, open, prospective study. A total of 620 breast cancer patients meeting the exclusion criteria were included and assigned to the IORT group and the WBI group according to the patients' wishes. The IORT group received intraoperative radiotherapy with a regimen of 50-KF-x 20Gy/1f, and the WBI group received whole milk external irradiation with a regimen of 50Gy/25f. If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area. If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. The clinical standard treatment regimen (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

Conditions

• Breast Cancer
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	radiotherapy	If the postoperative paraffin pathology of patients in the IORT group indicated positive axillary lymph nodes, the radiologist should determine whether to irradiate the whole milk and lymph nodes in the drainage area.If the postoperative pathology of patients in the WBI group indicated the need for chemotherapy, radiotherapy was initiated within 6 weeks after the end of chemotherapy, allowing both endocrine therapy and radiotherapy to be performed simultaneously. Clinical standard treatment plan (chemotherapy, endocrine therapy, etc.) was developed based on postoperative pathological and immunohistochemical reports.

Timeline

• Start date: 2020-11-19
• Primary completion: 2026-11-19
• Completion: 2026-11-19
• First posted: 2024-04-19
• Last updated: 2025-09-15

Locations

1 site across 1 country: China