A Phase 3 trial investigating hypofractionated versus conventional radiotherapy after prosthetic breast reconstruction in Breast Cancer patients reached primary completion on 2025-12-31. The study enrolled 190 participants.

Background

Breast cancer treatment often involves mastectomy, followed by radiation therapy and breast reconstruction. For patients undergoing total mastectomy with immediate prosthetic reconstruction, the optimal radiation therapy approach is a subject of ongoing research. Conventional fractionated radiotherapy (CFRT) has been a standard, but hypofractionated radiotherapy (HFRT) offers a shorter treatment duration, potentially improving patient convenience and resource utilization. This trial aims to compare these two approaches in the specific context of prosthetic breast reconstruction, focusing on patient outcomes and reconstruction integrity.

Trial design

This Phase 3 study, NCT07084519, is designed to enroll 190 participants across conditions including Breast Cancer, Breast Reconstruction, and Radiation Oncology. The trial investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. The HFRT arm involves 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks), while the control arm uses CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). The primary endpoint is the reconstruction failure rate, encompassing events such as implant removal and capsular contracture.

What this means

The primary completion of this Phase 3 trial signifies a significant step towards understanding the optimal radiotherapy approach for breast cancer patients with prosthetic reconstruction. While no outcome data has been released yet, the completion of the study's primary data collection phase means that analysis of the reconstruction failure rate, the primary endpoint, can now proceed. The findings from this trial are anticipated to provide valuable evidence for clinicians in selecting between hypofractionated and conventional radiotherapy, potentially impacting treatment protocols and patient quality of life for individuals undergoing breast cancer treatment with immediate implant reconstruction.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The event was recorded on 2025-12-31 for the study NCT07084519, titled "Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction", on clinicaltrials.gov.