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

December 9, 2024 updated by: University Hospital, Basel, Switzerland

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
382

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Zürich
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital Harvard Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in BREAST-Q scale
Time Frame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
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
Time Frame: within 24 months after mastectomy (screening, day 10, and months 1, 6, 12 and 24)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
loss of expander or implant
Time Frame: within 24 months of undergoing mastectomy and immediate reconstruction
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
Time Frame: within 24 months of undergoing mastectomy and immediate reconstruction
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
Time Frame: within 24 months of undergoing mastectomy and immediate reconstruction
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
Time Frame: over 24 months since mastectomy
compare patient satisfaction after pre-pectoral or sub-pectoral IBBR
over 24 months since mastectomy
animation deformity
Time Frame: before and 24 months after the mastectomy
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
Time Frame: before and 24 months after the mastectomy
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
Time Frame: before and 24 months after the mastectomy
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)
Time Frame: until 10 years after mastectomy and IBBR.
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
Time Frame: at baseline and after 24 months
evaluated by patients using a four point scale: excellent, good, regular, bad.
at baseline and after 24 months
total number of operative procedures
Time Frame: until 24 months after mastectomy
assess the burden on patients by total number of operative procedures
until 24 months after mastectomy
length of hospital stay (index hospitalization and overall)
Time Frame: until 24 months after randomization
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
Time Frame: from admission for mastectomy until 24 months after randomization
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
Time Frame: at baseline and after 24 months
evaluated by local physicians using a four point scale: excellent, good, regular, bad.
at baseline and after 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Walter Weber, Prof. Dr. med, Division of Breast Surgery, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-00256; ch18Weber4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Reconstruction

Clinical Trials on pre-pectoral IBBR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings