Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial
Andrea L Pusic,
Matthias Schwenkglenks,
Karin Ribi,
Lars G Hemkens,
Jane Shaw,
Christian Kurzeder,
Shelley Potter,
Joerg Heil,
Heiner C Bucher,
Frank Zimmermann,
Sherko Kuemmel,
Elisabeth A Kappos,
Alexandra Schulz,
Meredith M Regan,
Giusi Moffa,
Yves Harder,
Mathias K Fehr,
Thomas Holzbach,
Jian Farhadi,
Colin Simonson,
Michael Knauer,
Ralph Verstappen,
Daniel Zwahlen,
Rosine Mucklow,
Vesna Bjelic-Radisic,
Amelia Chiorescu,
Yoon S Chun,
Subrina Farah,
Chen Xiaosong,
Linda Nigard,
Roland Reitsamer,
Maik Hauschild,
Ilario Fulco,
Christoph Tausch,
Thomas Fischer,
Dimitri Sarlos,
Mihai A Constantinescu,
Judith E Lupatsch,
Florian Fitzal,
Zoltan Matrai,
Jana de Boniface,
Martin Haug,
Walter P Weber
Affiliations
Andrea L Pusic
Department of Surgery, Brigham Health, Brigham and Women`s Hospital, Boston, Massachusetts, USA
Matthias Schwenkglenks
associate professor
Karin Ribi
9 Quality of Life Office, International Breast Cancer Study Group Coordinating Center, Bern, Switzerland
Lars G Hemkens
senior scientist
Jane Shaw
Department of Pain Medicine, James Cook University Hospital, Middlesbrough, UK
Christian Kurzeder
University Hospital Basel, Basel, Switzerland
Shelley Potter
Population Health Sciences, University of Bristol Medical School, Bristol, UK
Joerg Heil
45 Department of Obstetrics and Gynecology, University Breast Unit, University Women’s Hospital Heidelberg, Heidelberg, Germany
Heiner C Bucher
professor
Frank Zimmermann
3 University of Basel, Basel, Switzerland
Sherko Kuemmel
35 Breast Unit, Kliniken Essen-Mitte, Essen, Germany
Elisabeth A Kappos
1 Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland
Alexandra Schulz
3 University of Basel, Basel, Switzerland
Meredith M Regan
1 Harvard Medical School, Boston, Massachussetts, USA
Giusi Moffa
8 Department of Mathematics and Computer Science, University of Basel, Basel, Switzerland
Yves Harder
7 Department of Plastic, Reconstructive and Aesthetic Surgery, Ospedale Regionale di Lugano and Centro di Senologia della Svizzera Italiana, Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland
Mathias K Fehr
12 Department of Gynecology and Obstetrics, Cantonal Hospital Frauenfeld, Frauenfeld, Switzerland
Thomas Holzbach
16 Department of Hand and Plastic Surgery, Spital Thurgau AG, Frauenfeld, Thurgau, Switzerland
Jian Farhadi
3 University of Basel, Basel, Switzerland
Colin Simonson
20 Brustzentrum Spital Sitten, Sitten, Switzerland
Michael Knauer
Pathology and Laboratory Medicine, Division of Clinical Biochemistry, London Health Sciences Centre, London, Ontario, Canada
Ralph Verstappen
22 Breast Center St. Gallen, St. Gallen Cantonal Hospital, St. Gallen, Switzerland
Daniel Zwahlen
Department of Radiation Oncology, Kantonsspital Winterthur, Winterthur, Switzerland
30 Breast Unit, University Hospital Helios Wuppertal, University Witten Herdecke, Wuppertal, Germany
Amelia Chiorescu
31 Department of Breast, Endocrine tumours and Sarcoma, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden
Yoon S Chun
11 Division of Plastic and Reconstructive Surgery, Department of Surgery, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts, USA
Subrina Farah
5 IBCSG Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Chen Xiaosong
33 Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Linda Nigard
34 Södersjukhuset, Bröstsektionen, Kirurgkliniken, Stockholm, Sweden
Roland Reitsamer
37 Breast Center Salzburg, University Clinic Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria
Maik Hauschild
38 Department of Gynecology and Obstetrics, Gesundheitszentrum Fricktal, Rheinfelden, Switzerland
Ilario Fulco
1 Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland
Christoph Tausch
18 Breast Center Zurich, Zurich, Switzerland
Thomas Fischer
Institute for Molecular and Clinical Immunology, Otto von Guericke Universitat, Magdeburg, Germany
Dimitri Sarlos
41 Department of Obstetrics and Gynecology, Kantonsspital Aarau AG, Aarau, Switzerland
Mihai A Constantinescu
42 Department of Plastic and Hand Surgery, Inselspital University Hospital, Bern, Switzerland
Judith E Lupatsch
26 Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland
Florian Fitzal
44 Breast Health Center and Department of Surgery, Medical University, Vienna, Austria
Zoltan Matrai
46 National Institute of Oncology, Department of Breast and Sarcoma Surgery, Budapest, Hungary
Jana de Boniface
6 Breast Unit, Capio St. Göran’s Hospital, Stockholm, Sweden
Martin Haug
1 Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland
Walter P Weber
1 Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland
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.
