Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC (OPBC-02PREPEC)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Reconstruction; Implant-Based Breast Reconstruction (IBBR)
• Intervention / Treatment: Procedure: pre-pectoral IBBR; Procedure: sub-pectoral IBBR

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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walter Weber, Prof. Dr. med; Phone Number: +41 61 328 61 49; Email: walter.weber@usb.ch
• Study Contact Backup: Name: Martin Haug, Prof. Dr. med; Phone Number: +41 61 265 7195; Email: martin.haug@usb.ch

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Universitätsklinik für Frauenheilkunde und Geburtshilfe
  • Wien, Austria, 1090
    • Medizinische Universität Wien
• Germany
  • Duisburg, Germany
    • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Klinik für Frauenheilkunde, Geburtshilfe, Gynäkologische Onkologie & Senologie
  • Essen, Germany, 45136
    • KEM | Evang. Kliniken Essen-Mitte
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Wuppertal, Germany
    • Landesfrauenklinik, Senologie und Brustzentrum
• Hungary
  • Budapest, Hungary, 1122
    • National Institute of Oncology
• Italy
  • Roma, Italy
    • Universitario "Agostino Gemelli" di Roma, Unità Operativa di Chirurgia Senologica
  • Trento, Italy
    • Ospedale Santa Chiara, Breast Surgical Oncology/Oncoplastic Surgery. Breast Center
• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital
  • Stockholm, Sweden, 11281
    • Capio S:t Görans Hospital
  • Stockholm, Sweden, 11281
    • Södersjukhuset
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau AG
  • Aarau, Switzerland, 5000
    • Klinik Hirslanden Brustzentrum Aarau
  • Basel, Switzerland, 4031
    • University Hospital Basel, Division of Breast Surgery
  • Bern, Switzerland, 3010
    • Universitätsklinik für Plastische- und Handchirurgie, Inselspital
  • Bern, Switzerland, 3011
    • Lindenhof Bern
  • Frauenfeld, Switzerland, 8501
    • Kantonsspital Frauenfeld
  • Rheinfelden, Switzerland, 4310
    • Gesundheitszentrum Fricktal
  • Viganello, Switzerland, 6962
    • Ospedale Regionale di Lugano
  • Zürich, Switzerland, 8008
    • Brust-Zentrum Zurich
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pre-pectoral IBBR	Procedure: pre-pectoral IBBR; The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.
Active Comparator: sub-pectoral IBBR	Procedure: sub-pectoral IBBR; The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BREAST-Q scale	compare the Quality of Life (QoL) with respect to long-term physical well-being (chest) after pre-pectoral or sub-pectoral IBBR. The BREAST-Q module specific to breast reconstruction version 2.0 consists of 13 independent scales covering health-related QoL domains and satisfaction domains. Each scale is scored to generate a numerical score on a scale from 0 (worst) to 100 (best).	within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
Change in EQ-5D-5L questionnaire	The 5-level version of the EQ-5D (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/Depression (5 answer levels each: no problems, slight problems, moderate problems, severe problems and extreme problems), resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension are combined into a 5-digit number that describes the patient's health state and is subsequently converted into a preference-based quality of life weight (utility) using an algorithm derived from population-based studies. In addition, patients are asked to rate their health on a vertical visual analogue scale (EQ VAS), where the anchors are labelled with 'The best health you can imagine' and 'The worst health you can imagine'.	within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
loss of expander or implant	compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of loss of expander or implant. Loss of expander or implant is defined as an unplanned surgical removal of expander/implant with or without immediate replacement.	within 24 months of undergoing mastectomy and immediate reconstruction
surgical complications	compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of surgical complications. The complications include: Wound dehiscence, Haematoma, Seroma, Implant/expander exposure/Extrusion, Implant/Expander rotation/malpositioning, Infection, Mastectomy skin flap necrosis, Capsular contraction, Lymphedema	within 24 months of undergoing mastectomy and immediate reconstruction
thromboembolic events	compare the safety of pre-pectoral and sub-pectoral IBBR, in terms of thromboembolic events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0	within 24 months of undergoing mastectomy and immediate reconstruction
patient satisfaction	compare patient satisfaction after pre-pectoral or sub-pectoral IBBR	over 24 months since mastectomy
animation deformity	compare animation deformity after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy	before and 24 months after the mastectomy
capsular contracture	compare capsular contracture after pre-pectoral or sub-pectoral IBBR by using pictures from before and 24 months after the mastectomy	before and 24 months after the mastectomy
aesthetic results	compare aesthetic results after pre-pectoral or sub-pectoral IBBR assessed by photographs of the breast taken in a standardized way. They will be evaluated by an experienced investigator who is blinded for group assignment. The blinded outcome assessment team will be trained to enter data for the two most widely used semi-automatic software for objective aesthetic evaluation, the 'Breast Cancer Conservative Treatment cosmetic results' (BCCT.core)	before and 24 months after the mastectomy
Recurrence-free survival (RFS)	RFS is defined as the time from randomization until the first documentation of any of the following events: local-regional occurrence or recurrence of invasive disease or ductal carcinoma in situ (DCIS), distant breast cancer metastasis, or death from any cause.	until 10 years after mastectomy and IBBR.
aesthetic results evaluated by patients	evaluated by patients using a four point scale: excellent, good, regular, bad.	at baseline and after 24 months
total number of operative procedures	assess the burden on patients by total number of operative procedures	until 24 months after mastectomy
length of hospital stay (index hospitalization and overall)	length of hospital stay (index hospitalization and overall) following randomization until discharge and the cumulative number of days the patient was hospitalized	until 24 months after randomization
total number of outpatient visits at the trial site and the emergency department	assess the burden on patients by total number of outpatient visits at the trial site and the emergency department	from admission for mastectomy until 24 months after randomization
aesthetic results evaluated by local physicians	evaluated by local physicians using a four point scale: excellent, good, regular, bad.	at baseline and after 24 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Walter Weber, Prof. Dr. med, Division of Breast Surgery, University Hospital Basel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): February 1, 2033

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: immediate breast reconstruction; skin-sparing mastectomy (SSM); nipple-sparing mastectomy (NSM); pre-pectoral breast implant; sub-pectoral breast implant
• Other Study ID Numbers: 2020-00256; ch18Weber4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No