NCT07037576

Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 104 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients

Detailed description

This study is a prospective, double-cohort study. It plans to enroll more than 104 patients with cT1-3N0-3M0 breast cancer for immediate prepectoral muscle prosthesis reconstruction or two-step breast reconstruction with expander/prosthesis, and they will receive postoperative radiotherapy. Record the changes of BREAST-Q scores of the patients before and after the operation, as well as information such as postoperative complications and capsular contracture. The primary endpoint was the BREAST-Q score at 12 months after the operation. The secondary endpoints included the success rate of breast reconstruction, surgical complications, cosmetic effects of the breast evaluated by doctors, the occurrence of capsular contracture, nipple and skin sensation, and tumor safety.

Conditions

• Breast Cancer Patients

Interventions

Type	Name	Description
PROCEDURE	Breast Reconstruction Surgery	Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy

Timeline

• Start date: 2025-05-20
• Primary completion: 2027-03-30
• Completion: 2028-03-30
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: China