Clinical Trial

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Recruiting Phase 3
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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)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-22.
Status change: Not Yet Recruiting → Recruiting 2026-06-17
Trial Details
NCT Number NCT07084519
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Breast Cancer, Breast Reconstruction, Radiation Oncology
Enrollment 506 participants
Start Date 2026-03-27
Primary Completion 2029-03-27 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-22