Breast Cancer FemaleGoBreastNCT03963427
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
A study testing Breast reconstruction in people with Breast Cancer Female and Surgery--Complications, run by Vastra Gotaland Region.
Trial summary
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female, Surgery--Complications
- What is being tested?
- Breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2008to 1 Dec 2025
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- DIEP is technically possible
- Unilateral mastectomy
- BMI<30
- ->18 years of age
- Unilateral mastectomy
- BMI<30
Who cannot join
- Scars on abdomen or back
- Bilateral mastectomy
- Previous liposuction abdomen
- 61 years of age or older
- Non-irradiated patients
- Bilateral mastectomy
- extensive scars on thorax
About this study
Official title: GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
- Conditions
- Breast Cancer Female, Surgery--Complications
- Being tested
- Breast reconstruction
- Keywords
- breast reconstruction, plastic surgery, microsurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstructionProcedure or surgery
Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
| Study group | Role | What they receive |
|---|---|---|
| Irradiated women | Other | Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Receives: Procedure: Breast reconstruction |
| Non-irradiated women | Other | Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages. Receives: Procedure: Breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic outcome
Photo evaluations
Measured: 1 year post-operatively
Secondary outcomes (8)
Breast related quality of life and satisfaction
Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life.
Measured: Pre-operatively and 3 years post-operatively
General quality of life measurement used for health economics
EuroQol-5 domensions-3 levels is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health.
Measured: Pre-operatively and 3 years post-operatively
Depression
Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.
Measured: Pre-operatively and 3 years post-operatively
General quality of life
Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life.
Measured: Pre-operatively and 3 years post-operatively
Early complication frequency
Complications described according to Clavien-Dindo
Measured: 2 weeks post-operatively
Long-term complications
Re-operations and corrections
Measured: Five years post-operatively
Health economics
Costs of different procedures
Measured: Five years post-operatively
Implant survival (Ancillary study)
Analysis of number of implants removed over time (Ethical permit: 2021-06131-02)
Measured: 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start8 Mar 2008
- Primary completion1 Apr 2020
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963427
- Sponsor's protocol ID
- Bröst-07:2-4
- Acronym
- GoBreast
- Status last verified
- Jun 2025
- First submitted
- 21 May 2019
- 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
Brorson F, Thorarinsson A, Kolby L, Elander A, Hansson E. Early complications in delayed breast reconstruction: A prospective, randomized study comparing different reconstructive methods in radiated and non-radiated patients. Eur J Surg Oncol. 2020 Dec;46(12):2208-2217. doi: 10.1016/j.ejso.2020.07.010. Epub 2020 Jul 26.
PubMed 32807615Brorson F, Elander A, Thorarinsson A, Hansson E. Patient Reported Outcome and Quality of Life After Delayed Breast Reconstruction - An RCT Comparing Different Reconstructive Methods in Radiated and Non-radiated Patients. Clin Breast Cancer. 2022 Dec;22(8):753-761. doi: 10.1016/j.clbc.2022.09.004. Epub 2022 Sep 17.
PubMed 36210311Thorarinsson A, Frojd V, Kolby L, Liden M, Elander A, Mark H. Patient determinants as independent risk factors for postoperative complications of breast reconstruction. Gland Surg. 2017 Aug;6(4):355-367. doi: 10.21037/gs.2017.04.04.
PubMed 28861376Thorarinsson A, Frojd V, Kolby L, Ljungdal J, Taft C, Mark H. Long-Term Health-Related Quality of Life after Breast Reconstruction: Comparing 4 Different Methods of Reconstruction. Plast Reconstr Surg Glob Open. 2017 Jun 21;5(6):e1316. doi: 10.1097/GOX.0000000000001316. eCollection 2017 Jun.
PubMed 28740762Thorarinsson A, Frojd V, Kolby L, Modin A, Lewin R, Elander A, Mark H. Blood loss and duration of surgery are independent risk factors for complications after breast reconstruction. J Plast Surg Hand Surg. 2017 Oct;51(5):352-357. doi: 10.1080/2000656X.2016.1272462. Epub 2017 Jan 26.
PubMed 28122466Thorarinsson A, Frojd V, Kolby L, Lewin R, Molinder N, Lundberg J, Elander A, Mark H. A retrospective review of the incidence of various complications in different delayed breast reconstruction methods. J Plast Surg Hand Surg. 2016;50(1):25-34. doi: 10.3109/2000656X.2015.1066683. Epub 2015 Sep 11.
PubMed 26360138Brorson F, Paganini A, Simons K, Elander A, Hansson E. Long-term implant survival in delayed breast reconstruction. BJS Open. 2025 Jul 1;9(4):zraf071. doi: 10.1093/bjsopen/zraf071.
PubMed 40613789
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
- GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods
- ClinicalTrials.gov ID
- NCT03963427
- Acronym / sponsor ID
- GoBreast / Bröst-07:2-4
- Conditions
- Breast Cancer Female, Surgery--Complications
- Keywords
- breast reconstruction, plastic surgery, microsurgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 8 Mar 2008 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 May 2019 (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.
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irradiated women | Other | Procedure: Breast reconstructionIrradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. |
| Non-irradiated women | Other | Procedure: Breast reconstructionNon-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-60
- DIEP is technically possible
- Unilateral mastectomy
- BMI<30
- ->18 years of age
Key exclusion criteria (7 listed)
- Scars on abdomen or back
- Bilateral mastectomy
- Previous liposuction abdomen
- 61 years of age or older
- Non-irradiated patients
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 |
|---|---|---|
| Breast reconstructionIrradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages. | Procedure or surgery | Irradiated women, Non-irradiated women |
Primary outcome
Aesthetic outcome
Time frame: 1 year post-operatively
Photo evaluations
8 secondary outcomes
Breast related quality of life and satisfaction
Time frame: Pre-operatively and 3 years post-operatively
General quality of life measurement used for health economics
Time frame: Pre-operatively and 3 years post-operatively
Depression
Time frame: Pre-operatively and 3 years post-operatively
General quality of life
Time frame: Pre-operatively and 3 years post-operatively
Early complication frequency
Time frame: 2 weeks post-operatively
Long-term complications
Time frame: Five years post-operatively
Health economics
Time frame: Five years post-operatively
Implant survival (Ancillary study)
Time frame: 19 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.
- Results publication: PubMed 32807615Brorson F, Thorarinsson A, Kolby L, Elander A, Hansson E. Early complications in delayed breast reconstruction: A prospective, randomized study comparing different reconstructive methods in radiated and non-radiated patients. Eur J Surg Oncol. 2020 Dec;46(12):2208-2217. doi: 10.1016/j.ejso.2020.07.010. Epub 2020 Jul 26.
- Results publication: PubMed 36210311Brorson F, Elander A, Thorarinsson A, Hansson E. Patient Reported Outcome and Quality of Life After Delayed Breast Reconstruction - An RCT Comparing Different Reconstructive Methods in Radiated and Non-radiated Patients. Clin Breast Cancer. 2022 Dec;22(8):753-761. doi: 10.1016/j.clbc.2022.09.004. Epub 2022 Sep 17.
- Results publication: PubMed 28861376Thorarinsson A, Frojd V, Kolby L, Liden M, Elander A, Mark H. Patient determinants as independent risk factors for postoperative complications of breast reconstruction. Gland Surg. 2017 Aug;6(4):355-367. doi: 10.21037/gs.2017.04.04.
- Results publication: PubMed 28740762Thorarinsson A, Frojd V, Kolby L, Ljungdal J, Taft C, Mark H. Long-Term Health-Related Quality of Life after Breast Reconstruction: Comparing 4 Different Methods of Reconstruction. Plast Reconstr Surg Glob Open. 2017 Jun 21;5(6):e1316. doi: 10.1097/GOX.0000000000001316. eCollection 2017 Jun.
- Results publication: PubMed 28122466Thorarinsson A, Frojd V, Kolby L, Modin A, Lewin R, Elander A, Mark H. Blood loss and duration of surgery are independent risk factors for complications after breast reconstruction. J Plast Surg Hand Surg. 2017 Oct;51(5):352-357. doi: 10.1080/2000656X.2016.1272462. Epub 2017 Jan 26.
- Results publication: PubMed 26360138Thorarinsson A, Frojd V, Kolby L, Lewin R, Molinder N, Lundberg J, Elander A, Mark H. A retrospective review of the incidence of various complications in different delayed breast reconstruction methods. J Plast Surg Hand Surg. 2016;50(1):25-34. doi: 10.3109/2000656X.2015.1066683. Epub 2015 Sep 11.
- Derived from this study: PubMed 40613789Brorson F, Paganini A, Simons K, Elander A, Hansson E. Long-term implant survival in delayed breast reconstruction. BJS Open. 2025 Jul 1;9(4):zraf071. doi: 10.1093/bjsopen/zraf071.
- Research groupLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Breast reconstruction in people with Breast Cancer Female and Surgery--Complications, run by Vastra Gotaland Region.
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 7 inclusion and 7 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: under way, not looking for participants, 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic outcome (time frame: 1 year post-operatively). 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 NCT03963427, which also lists 7 linked publications.
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.