Breast CancerGoBreast IINCT06195865
Autologous vs. Implant-based Breast Reconstruction
A study testing DIEP-flap and Implant in people with Breast Cancer, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DIEP-flap and Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Apr 2024to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Comorbidity and/or drugs that affect wound healing.
- Unstable psychiatric co-morbidity
- Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg, 413 45
Emma Hansson, PhD, +46 31 342 10 00, emma.hansson.2@gu.se
- Recruiting
Sahlgrenska university hospital
Gothenburg
Emma Hansson, PhD
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- DIEP-flap, Implant
- Keywords
- Breast reconstruction, DIEP-flap, Implant-based breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIEP-flapProcedure or surgery
Breast reconstruction with a deep inferior epigastric perforator flap
ImplantProcedure or surgery
Breast reconstruction with an implant-based technique
| Study group | Role | What they receive |
|---|---|---|
| Randomised DIEP flap | Active comparator | Not described Receives: Procedure: DIEP-flap |
| Randomised implant-based | Active comparator | Not described Receives: Procedure: Implant |
| Preference DIEP-flap | Active comparator | Not described Receives: Procedure: DIEP-flap |
| Preference implant-based | Active comparator | Not described Receives: Procedure: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the breast/s and breast-specific quality of life
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.
Measured: 5 years
Cost-effectiveness
The net cost divided for society by changes in health outcomes measured with Breast-Q and EQ5D.
Measured: 5 years+ simulation model based on 20 years
Secondary outcomes (7)
Complications
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.
Measured: 5 years
Surgical revisions
All operations performed will be recorded and classified according to the international classification of disease in the operation planing program Orbit.
Measured: 5 years
Satisfaction with the donor-site
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.
Measured: 5 years
Symptoms of depression and anxiety
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.
Measured: 5 years
Body image
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.
Measured: 5 years
Body investment
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.
Measured: 5 years
Generic quality of life
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195865
- Sponsor's protocol ID
- 2023-04754-01
- Other IDs
- 2023
- Acronym
- GoBreast II
- Status last verified
- Jun 2025
- First submitted
- 21 Dec 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansson E, Lofstrand J, Larsson C, Uusimaki A, Svensson K, Ekman A, Svensson M, Paganini A. Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction. BMJ Open. 2024 Jul 17;14(7):e084025. doi: 10.1136/bmjopen-2024-084025.
PubMed 39019639
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous vs. Implant-based Breast Reconstruction: a Partially Randomised Patient Preference, Superiority Trial
- ClinicalTrials.gov ID
- NCT06195865
- Acronym / sponsor ID
- GoBreast II / 2023-04754-01
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, DIEP-flap, Implant-based breast reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomised DIEP flap | Active comparator | Procedure: DIEP-flap |
| Randomised implant-based | Active comparator | Procedure: Implant |
| Preference DIEP-flap | Active comparator | Procedure: DIEP-flap |
| Preference implant-based | Active comparator | Procedure: Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- ASA > 2
- BMI > 30 kg/m2
- Smoking1 radiotherapy to the breast in question.
- Radiotherapy is expected post-operatively.
- Locally advanced breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIEP-flapBreast reconstruction with a deep inferior epigastric perforator flap | Procedure or surgery | Preference DIEP-flap, Randomised DIEP flap |
| ImplantBreast reconstruction with an implant-based technique | Procedure or surgery | Preference implant-based, Randomised implant-based |
Primary outcome
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.
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.
7 secondary outcomes
Complications
Time frame: 5 years
Surgical revisions
Time frame: 5 years
Satisfaction with the donor-site
Time frame: 5 years
Symptoms of depression and anxiety
Time frame: 5 years
Body image
Time frame: 5 years
Body investment
Time frame: 5 years
Generic quality of life
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 39019639Hansson E, Lofstrand J, Larsson C, Uusimaki A, Svensson K, Ekman A, Svensson M, Paganini A. Gothenburg Breast reconstruction (GoBreast) II protocol: a Swedish partially randomised patient preference, superiority trial comparing autologous and implant-based breast reconstruction. BMJ Open. 2024 Jul 17;14(7):e084025. doi: 10.1136/bmjopen-2024-084025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIEP-flap and Implant in people with Breast Cancer, run by Vastra Gotaland Region at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hansson, PhD (+46313421000, emma.em.hansson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the breast/s and breast-specific quality of life (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.