Clinical trial NCT04293146: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
Official title: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy (OPBC-02/ PREPEC): a Pragmatic, Multicenter, Randomized, Superiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Reconstruction
Implant-Based Breast Reconstruction (IBBR)
Keywords: skin-sparing mastectomy (SSM)
nipple-sparing mastectomy (NSM)
immediate breast reconstruction
pre-pectoral breast implant
sub-pectoral breast implant
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2020-03-03
Enrollment: 382
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will objectively assess the results and complication of two surgical techniques and thus provide evidence to assess whether there are differences between these techniques.
Primary purpose: OTHER

Brief summary: This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.

Detailed description: This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR for patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy for prevention or treatment of breast cancer.The aim is to adhere to standard of care as much as possible to follow the pragmatic trial design to generate data that are applicable to today's practice. Therefore, surgeons are allowed to use their preferred Acellular Dermal Matrix (ADM), synthetic meshes, expanders and implants, thereby offering practitioners considerable leeway in deciding how to perform the procedure. For the same reason, both the one- and two-staged IBBR approaches are allowed when studying pre- versus sub-pectoral IBBR.

Eligibility criteria: Inclusion Criteria:

* Written informed consent according to ICH/GCP regulations prior to any trial specific procedures
* Patients undergoing NSM or SSM and IBBR in the therapeutic or risk-reducing Setting
* Ability to complete the Quality of Life questionnaires

Exclusion Criteria:

* No indication for IBBR according to clinical judgment of the treating surgeon
* Skin flaps inadequate for pre-pectoral IBBR.

Primary outcomes:
measure: Change in BREAST-Q scale
timeFrame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
measure: Change in EQ-5D-5L questionnaire
timeFrame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
Secondary outcomes:
measure: loss of expander or implant
timeFrame: within 24 months of undergoing mastectomy and immediate reconstruction
measure: surgical complications
timeFrame: within 24 months of undergoing mastectomy and immediate reconstruction
measure: thromboembolic events
timeFrame: within 24 months of undergoing mastectomy and immediate reconstruction
measure: patient satisfaction
timeFrame: over 24 months since mastectomy
measure: animation deformity
timeFrame: before and 24 months after the mastectomy
measure: capsular contracture
timeFrame: before and 24 months after the mastectomy
measure: aesthetic results
timeFrame: before and 24 months after the mastectomy
measure: Recurrence-free survival (RFS)
timeFrame: until 10 years after mastectomy and IBBR.
measure: aesthetic results evaluated by patients
timeFrame: at baseline and after 24 months
measure: total number of operative procedures
timeFrame: until 24 months after mastectomy
measure: length of hospital stay (index hospitalization and overall)
timeFrame: until 24 months after randomization
measure: total number of outpatient visits at the trial site and the emergency department
timeFrame: from admission for mastectomy until 24 months after randomization
measure: aesthetic results evaluated by local physicians
timeFrame: at baseline and after 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital Harvard Medical School
state: Massachusetts
city: Salzburg
country: Austria
facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Duisburg
country: Germany
facility: Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie
city: Essen
country: Germany
facility: KEM | Evang. Kliniken Essen-Mitte
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Wuppertal
country: Germany
facility: Landesfrauenklinik, Senologie und Brustzentrum
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Roma
country: Italy
facility: Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica
city: Trento
country: Italy
facility: Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center
city: Stockholm
country: Sweden
facility: Capio S:t Görans Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Aarau
country: Switzerland
facility: Klinik Hirslanden Brustzentrum Aarau
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Breast Surgery
city: Bern
country: Switzerland
facility: Universitätsklinik für Plastische- und Handchirurgie, Inselspital
city: Bern
country: Switzerland
facility: Lindenhof Bern
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld
city: Rheinfelden
country: Switzerland
facility: Gesundheitszentrum Fricktal
city: Viganello
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Zürich
country: Switzerland
facility: Brust-Zentrum Zürich
Study officials:
affiliation: Division of Breast Surgery, University Hospital Basel
name: Walter Weber, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kappos EA, Schulz A, Regan MM, Moffa G, Harder Y, Ribi K, Potter S, Pusic AL, Fehr MK, Hemkens LG, Holzbach T, Farhadi J, Simonson C, Knauer M, Verstappen R, Bucher HC, Zwahlen D, Zimmermann F, Schwenkglenks M, Mucklow R, Shaw J, Bjelic-Radisic V, Chiorescu A, Chun YS, Farah S, Xiaosong C, Nigard L, Kuemmel S, Reitsamer R, Hauschild M, Fulco I, Tausch C, Fischer T, Sarlos D, Constantinescu MA, Lupatsch JE, Fitzal F, Heil J, Matrai Z, de Boniface J, Kurzeder C, Haug M, Weber WP. Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial. BMJ Open. 2021 Sep 2;11(9):e045239. doi: 10.1136/bmjopen-2020-045239.