Breast Reconstruction and Neoadjuvant Radiotherapy

The purpose the BRENAR pilot study is to assess acute post-surgical complications following mastectomy and immediate breast reconstruction after neoadjuvant radiotherapy (NART). The investigators hypothesize that NART will avoid the negative effects of postmastectomy radiotherapy (PMRT) on the capsule of an implant, or on the skin and underlying tissue of an autologous flap, and would therefore lead to better cosmetic results, better quality of life and less complications compared to PMRT. If this hypothesis is confirmed, NART would allow more patients to undergo an immediate reconstruction resulting in superior cosmetic results and quality of life. Furthermore, the use of RT in a neoadjuvant setting could potentially result in a shorter overall loco-regional treatment time from diagnosis to receiving the last locoregional treatment. However, this pilot study will mainly assess whether or not the post-surgical complications of breast reconstruction with NART are acceptable. Further study to investigate long term quality of life and oncologic follow-up results will be conducted after this pilot study, if complication rates are acceptable.

NCT Number	NCT05216900
Lead Sponsor	UMC Utrecht Collaborators: Alexander Monro Hospital, Bilthoven, Amsterdam UMC, Cancer Center Amsterdam grant for innovative research
Conditions	Breast Cancer
Enrollment	20 participants
Start Date	2023-04-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2026-12-04 (estimated)
Updated on ClinicalTrials.gov	2024-06-21