Abstract OT-23-01: Examining and comparing the temporal changes and results of cosmetic, quality of life and patient satisfaction achieved with immediate and delayed-immediate implant-based breast reconstruction procedures and contralateral symmetrisation techniques after skin-sparing mastectomies with unilateral simple mastectomy and with bilateral skin-sparing mastectomies and immediate implant-based breast reconstructive surgeries. (ClinicalTrials.gov Identifier: NCT04356235)
Authors: Újhelyi Mihály , Sávolt Ákos , Huszár Orsolya , Ping Orsolya , Mészáros Norbert , Jani Nóra , Újlaki Mátyás , Kenessey István , József Zsófia , Mátrai Zoltán 
Published: February 2021

Abstract
IntroductionThe immediate (I-BR) or delayed-immediate (DI-BR) implant-based breast reconstruction (BR) of the affected breast following nipple, areola, skin-sparing mastectomy (NSM, ASM, SSM) techniques requires almost in all cases symmetrization of the contralateral breast. The long term results of implant-based BR (subpectoral or prepectoral) and symmetrization following advanced postmastectomy BR techniques significantly decrease over time and later result in a limited patient satisfaction rate. Beyond the satisfactory early results BRs, there are only limited long term data on cosmetics and patient satisfaction. In fact with time patient dissatisfaction necessitates repeated surgeries, with an extra load for both to the patient and the health system. The aim of the study is to gain high quality data about the deteriorating cosmetic outcomes of bilateral BRs on the long term. Trial design In this response-adaptive prospective randomized study patients are sub-grouped into 6 study groups after BR surgery with silicone implant (following uni- or bilateral NSM, ASM, SSM) with symmetrization in case of unilateral mastectomy (mastopexy and/or silicone implant and/or mesh sling technique to suspend the breast with or without reduction) or simple mastectomy without symmetrization. The planned number of patients is a minimum of 528 cases. The measurements of the breast, the ptosis, photo documentation using valid BCCT.core software, BREAST-Q questionnaire and Likert scale are performed preoperatively, 4 weeks after delayed BR with symmetrization, 3 months after, every 6 months for 5 years.
Primary endpoint Using correlation analysis to measure objective changes over time in the quality of life (QoL) and patient satisfaction associated with the symmetry achieved by different surgical techniques up to five years of follow-up. To compare the QoL and the satisfaction rate in the control group with a simple mastectomy, bilateral SSM, ASM, NSM and BR.
Secondary endpoint To determine the prognostic factors, patient subgroups, and surgical techniques associated with patients, surgery, and oncological therapies in an optimal way. Furthermore, the study should give relevant data about the oncoplastic concept of prophylactic SSM, ASM, or NSM on the contralateral side and BR, without the presence of hereditary breast and ovarian cancer syndrome, using the same surgical technique than on the affected side. The long term PRO results of postmastectomy BR should be necessarily part of the initial patient information in the future.
Inclusion criteria- Under the age of 65 with uni- or bilateral primary breast cancer, needing advanced mastectomy independently of the axillary surgery, having I-BR os DI-BR on the ipsilateral side and symmetrization on the contralateral side - Control group: patients under 65 years with unilateral simplex mastectomy without BR. Exclusion criteria-Pregnancy-associated breast cancer-Prior breast surgery and/or radiotherapy -Severe non-surgical complication-Long-term steroid usage
Present accrual and target accrual The trial was activated on 22 April 2020. As of 5 July, 23 patients have been randomized. Accrual is currently running according to protocol and is planned until 2025. Interim analysis performed after 2 years’ median follow-up period. The final analysis is performed 5 years after closing the patient inclusion period.
Citation Format: Mihály Újhelyi, Ákos Sávolt, Orsolya Huszár, Orsolya Ping, Norbert Mészáros, Nóra Jani, Mátyás Újlaki, István Kenessey, Zsófia József, Zoltán Mátrai. Examining and comparing the temporal changes and results of cosmetic, quality of life and patient satisfaction achieved with immediate and delayed-immediate implant-based breast reconstruction procedures and contralateral symmetrisation techniques after skin-sparing mastectomies with unilateral simple mastectomy and with bilateral skin-sparing mastectomies and immediate implant-based breast reconstructive surgeries. (ClinicalTrials.gov Identifier: NCT04356235) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-23-01.