Prepectoral versus subpectoral
implant-based breast reconstruction after
skin-sparing mastectomy or nipple-sparing
mastectomy (OPBC-02/ PREPEC): a pragmatic,
multicentre, randomised, superiority trial
Authors: Kappos Elisabeth A , Schulz Alexandra , Regan Meredith M , Moffa Giusi , Harder Yves , Ribi Karin , Potter Shelley , Pusic Andrea L , Fehr Mathias K , Hemkens Lars G , Holzbach Thomas , Farhadi Jian , Simonson Colin , Knauer Michael , Verstappen Ralph , Bucher Heiner C , Zwahlen Daniel , Zimmermann Frank , Schwenkglenks Matthias , Mucklow Rosine , Shaw Jane , Bjelic-Radisic Vesna , Chiorescu Amelia , Chun Yoon S , Farah Subrina , Xiaosong Chen , Nigard Linda , Kuemmel Sherko , Reitsamer Roland , Hauschild Maik , Fulco Ilario , Tausch Christoph , Fischer Thomas , Sarlos Dimitri , Constantinescu Mihai A , Lupatsch Judith E , Fitzal Florian , Heil Joerg , Matrai Zoltan , de Boniface Jana , Kurzeder Christian , Haug Martin , Weber Walter P 
Published: February 2022

Introduction

The emphasis on aesthetic outcomes and
quality of life (QoL) has motivated surgeons to
develop skin-sparing or nipple-sparing mastectomy
(SSM/ NSM) for breast cancer treatment or
prevention. During the same operation, a so-called
immediate breast reconstruction is performed. The
breast can be reconstructed by positioning of a
breast implant above (prepectoral) or below
(subpectoral) the pectoralis major muscle or by
using the patients’ own tissue (autologous
reconstruction). The optimal positioning of the
implant prepectoral or subpectoral is currently
not clear. Subpectoral implant-based breast
reconstruction (IBBR) is still standard care in
many countries, but prepectoral IBBR is
increasingly performed. This heterogeneity in
breast reconstruction practice is calling for
randomised clinical trials (RCTs) to guide
treatment decisions.

Methods and analysis

International, pragmatic, multicentre,
randomised, superiority trial. The primary
objective of this trial is to test whether
prepectoral IBBR provides better QoL with respect
to long-term (24 months) physical well-being
(chest) compared with subpectoral IBBR for
patients undergoing SSM or NSM for prevention or
treatment of breast cancer. Secondary objectives
will compare prepectoral versus subpectoral IBBR
in terms of safety, QoL and patient satisfaction,
aesthetic outcomes and burden on patients. Total
number of patients to be included: 372 (186 per
arm).

Ethics and dissemination

This study will be conducted in compliance
with the Declaration of Helsinki. Ethical approval
has been obtained for the lead investigator’s site
by the Ethics Committee ‘Ethikkommission Nordwest-
und Zentralschweiz‘ (2020–00256, 26 March 2020).
The results of this study will be published in a
peer-reviewed medical journal, independent of the
results, following the Consolidated Standards of
Reporting Trials standards for RCTs and good
publication practice. Metadata describing the
type, size and content of the datasets will be
shared along with the study protocol and case
report forms on public repositories adhering to
the FAIR (Findability, Accessibility,
Interoperability, and Reuse) principles.

Trial registration number

NCT04293146.