NCT07084519

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction. Intervention: HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)

Conditions

• Breast Cancer
• Breast Reconstruction
• Radiation Oncology

Interventions

Type	Name	Description
RADIATION	hypofractionated radiotherapy	43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
RADIATION	conventional fractionated radiotherapy	50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

Timeline

• Start date: 2025-08-10
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China