Autologous vs. Implant-based Breast Reconstruction (GoBreast II)

June 30, 2025 updated by: Vastra Gotaland Region

Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Estimated)

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.
250

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 Locations

  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
          • Emma Hansson, PhD
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biological female
  • >18 years of age
  • American Society of anesthesiologist classification (ASA) 1-2
  • Patient must have had or be scheduled for a mastectomy
  • Ability to give informed consent
  • Ability to communicate in Swedish

Exclusion Criteria:

  • ASA > 2
  • BMI > 30 kg/m2
  • Smoking1 radiotherapy to the breast in question.
  • Radiotherapy is expected post-operatively.
  • Locally advanced breast cancer
  • Metastasised breast cancer
  • Comorbidity and/or drugs that affect wound healing.
  • Unstable psychiatric co-morbidity
  • Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Randomised DIEP flap
Procedure: DIEP-flap
Breast reconstruction with a deep inferior epigastric perforator flap
Active Comparator: Randomised implant-based
Procedure: Implant
Breast reconstruction with an implant-based technique
Active Comparator: Preference DIEP-flap
Procedure: DIEP-flap
Breast reconstruction with a deep inferior epigastric perforator flap
Active Comparator: Preference implant-based
Procedure: Implant
Breast reconstruction with an implant-based technique

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
Satisfaction with the breast/s and breast-specific quality of life
Time Frame: 5 years
Satisfaction with the breast/s and breast-specific quality of life measured with BREAST-Q reconstruction.The patient rates all items on 3-, 4-, and 5-point Likert-scales. A raw score, that is converted to a score 0-100, is calculated for each domain. A higher score indicates a greater satisfaction or better quality of life.
5 years
Cost-effectiveness
Time Frame: 5 years+ simulation model based on 20 years
The net cost divided for society by changes in health outcomes measured with Breast-Q and EQ5D.
5 years+ simulation model based on 20 years

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
Surgical revisions
Time Frame: 5 years
All operations performed will be recorded and classified according to the international classification of disease in the operation planing program Orbit.
5 years
Satisfaction with the donor-site
Time Frame: 5 years
Satisfaction with the donor site will be measured with the abdominal domain of Breast-Q.The patient rates all items on 3-, 4-, and 5-point Likert-scales. A raw score, that is converted to a score 0-100, is calculated for each domain. A higher score indicates a greater satisfaction or better quality of life.
5 years
Symptoms of depression and anxiety
Time Frame: 5 years
Symptoms of depression and anxiety will be measured with the Hospital Anxiety and Depression Scale (HADS).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.
5 years
Body image
Time Frame: 5 years
Body image will be measured with the Multidimensional Body-Self Relation Questionnaire (MBSRQ).Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.
5 years
Body investment
Time Frame: 5 years
Body investment will be measured with the Appearance Schemas Inventory-revised (ASI-R).Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.
5 years
Generic quality of life
Time Frame: 5 years
Generic quality of life will be measured with EuroQoL-5 dimensions (EQ-5D-3L).n EQ-5D-3L, the five dimensions each have three response levels of severity.Respondents are asked to choose the statement in each dimension that best describes their health status on the day they are surveyed. Their responses are coded as a number (1, 2, or 3) that corresponds to the respective level of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.
5 years
Complications
Time Frame: 5 years
Complications classified as types and according to the Clavien-Dindo Classification (CDC) of surgical complications. According to CDC all complications are graded from 1 (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to 5 (Patient demise). Comprehensive Complication Index (CCI) scores will also be used. The CCI is calculated from CDC as the sum of all complications that are weighted for their severity, yielding a scale from 0-100. A higher CCI means more severe and more complications. All participating surgeons will be given a list of study specific definitions of complications.
5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expectations
Time Frame: Pre-op
Pre-operative expectations will be measured with the BREAST-Q expectations domain. The patient rates all items on 3-, 4-, and 5-point Likert-scales. A raw score, that is converted to a score 0-100, is calculated for each domain. A higher score indicates a greater satisfaction or better quality of life.
Pre-op
Patient's goals with the reconstruction
Time Frame: Pre-op
patient's goals with the reconstruction will be documented using the PEGASUS instrument. Patients' Expectations and Goals of reconstruction. Assisting Shared Understanding of Surgery) tool to make the decision of whether they want a breast reconstruction. The tool is used to form a basis for a patient-centred dialogue around breast reconstruction.
Pre-op
Study with a trial (SWAT):The choice of breast reconstruction and the choice of reconstructive method.
Time Frame: Longitudinal - the same participants will be interviewed at allocation and 12 months after the reconstruction.
Qualitative study - participants will be recruited from the preference cohort.
Longitudinal - the same participants will be interviewed at allocation and 12 months after the reconstruction.
Study with a trial (SWAT):What makes a participant very satisfied or very dissatisfied.
Time Frame: 12 months after reconstruction
Qualitative study -Participants will be recruited from both cohorts among women who scored high/low, compared to the mean, on BREAST-Q outcome and satisfaction with breast/s.
12 months after reconstruction
Study with a trial (SWAT): Experiences with the trial process.
Time Frame: Different participants from both cohorts are interviewed at allocation, 3 and 12 months to explore if there are different themes at different time points.
Qualitative study -How the participant experienced the trial process, how it can be ameliorated to increase recruitment, retention, and follow-up rates of questionnaires and how participation information leaflet should be designed/written to maximize recruitment.
Different participants from both cohorts are interviewed at allocation, 3 and 12 months to explore if there are different themes at different time points.
Differences between the preference and the randomized cohort
Time Frame: Preoperatively and 12 months after reconstruction
Differences regarding demographic factors as well as pre-operative satisfaction with breasts, expectations, body-image, symptoms of depression and anxiety, and generic quality of life.
Preoperatively and 12 months after reconstruction

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.
Vastra Gotaland Region

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.
Göteborg University

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.
April 1, 2024

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.
December 31, 2028

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.
December 31, 2031

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).
December 21, 2023

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.
January 5, 2024

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.
January 8, 2024

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.
July 3, 2025

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.
June 30, 2025

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.
June 1, 2025

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.
  • 2023-04754-01

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.

Yes

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.

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