Breast Reconstruction and Neoadjuvant Radiotherapy
Breast Reconstruction and Neoadjuvant Therapy, a Changing Algorithm
UMC Utrecht
20 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
The study examines the delivery NART. In case of neoadjuvant chemotherapy, RT will start 6-8 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions per week, or a biologically equivalent dose will be applied. A mastectomy and a direct breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment. Breast reconstruction can be separated in the types of reconstruction, either reconstruction with a silicone implant or with only autologous tissue, of which the most common flap used is the Deep Inferior Epigastric Perforator (DIEP) flap.
Locations(1)
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NCT05216900