Breast CancerNCT02061527
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
A study testing Reconstruction with ADM., Skin or nipple sparing mastectomy and Reconstruction with implant in people with Breast Cancer, run by Karolinska University Hospital at 5 sites in 2 countries.
Trial summary
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment. 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?
- Reconstruction with ADM., Skin or nipple sparing mastectomy and Reconstruction with implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral)
- Patient agrees to participate in study and to sign an informed consent form
- Able and willing to return for all scheduled and required study visits
Who cannot join
- Is a smoker (patient having quit at least 4 weeks prior surgery can be included)
- BMI <18 or > 30
- Previous radiation therapy to the region at any time
- Insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies
- Predicted implant size <200 or >600 ml per investigator assessment
- Allergy to porcine
Show all 9Show fewer
- Pregnancy or lactating
- Current enrollment or plans to enroll in another clinical trial unless a retrospective study
- Neoadjuvant treatment with chemotherapy
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden4 sites
Falun Hospital, Department of Breast Surgery
Falun
Capio S:t Gorans Hospital
Stockholm
Karolinska University Hospital
Stockholm
Södersjukhuset AB
Stockholm
About this study
Official title: Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
Read the detailed description
OBJECTIVES: To evaluate the outcome of immediate breast reconstruction with Acellular Dermal Matrix (Strattice™), measuring safety, effectiveness, and costs. The primary outcome measure is number of unplanned surgical procedures.
STUDY DESIGN: A prospective randomized multicenter trial. One hundred and twenty patients with breast cancer will be enrolled into the study. Study duration will be two years from time of primary cancer surgery.
TRIAL DESIGN This is a randomized controlled multicenter trial, comparing IBR without (group A) and with (group B) the use of ADM. Participants eligible for the study are patients with breast cancer, planned for mastectomy, who wishes IBR with implants. Each participant is individually randomized to either be reconstructed using implants with total submuscular coverage (A) or reconstruction with ADM and partial muscle coverage (B).
Method of assigning patients to treatment groups:
After signing and dating the informed consent the patient is entered into the study. If all inclusion and none of the exclusion criteria are full filled, the patient will be randomized to group A or group B.
TREATMENT/ INTERVENTION The decision and treatment plan advocating mastectomy is based on multi disciplinary conference (MDT), and the diagnosis of invasive or pre-invasive (in situ) breast cancer is made on triple assessment. If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.
Randomization at enrollment is made with regard to the use of ADM or not, so both expander and direct-to-implant techniques will be utilized in both groups, depending on the quality of skin flaps at time of surgery.
RANDOMIZATION TYPE Patients will be allocated to treatment according to permuted block technique. The actual randomization will be performed using computer based system located at Regional Cancer Center (RCC) within Karolinska Institutet. In this system inclusion and exclusion criteria will be automatically checked before patients are randomized to treatment. The randomization process will be stratified for the participating units.
STATISTICAL METHODS The main endpoint to be analyzed is the proportion of unplanned reoperations after the initial breast reconstruction. The difference in proportions between the two groups will be presented as a difference in proportion together with a 95% confidence interval. Differences will be tested using Fishers Exact Test. Logistic regression will be used to take into account possible confounding factors.
STUDY MANAGEMENT Data recording: The investigators will ensure that all data from patient visits are entered promptly in ink, in the case report forms (CRF). The principal investigator must sign the final CRF page to attest to the accuracy and completeness of the data. The data from the CRFs are then transferred to a database.
Monitoring and audit: At periods not exceeding 3 months, centers will be contacted to discuss the progress of the trial, with the purpose to verify CRF data against source records for accuracy of data recording and collection.
- Conditions
- Breast Cancer
- Being tested
- Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant, Total submuscular coverage, Partial submuscular coverage
- Keywords
- ADM, Strattice, Breast reconstruction, Immediate breast reconstruction, IBR, Acellular dermal matrix, Biological mesh, Randomized controlled trial, RCT, Breast cancer, Implants, Mastectomy, Direct-to-implant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction with ADM.Procedure or surgery
Also called Strattice, ADM, Implant, Immediate breast reconstruction
If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.
Skin or nipple sparing mastectomyProcedure or surgery
Also called Mastectomy, Skin sparing mastectomy, Nipple sparing mastectomy, Acellular dermal matrix
Mastectomy for invasive or pre-invasive breast cancer
Reconstruction with implantProcedure or surgery
Also called Implant, Mastectomy, Acellular dermal matrix, Direct-to-implant
Immediate breast reconstruction with implant
Total submuscular coverageProcedure or surgery
Implant based breast reconstruction with total submuscular coverage
Partial submuscular coverageProcedure or surgery
Implant based breast reconstruction with partial submuscular coverage
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction with ADM | Experimental | Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage. Receives: Procedure: Reconstruction with ADM.; Procedure: Skin or nipple sparing mastectomy; Procedure: Reconstruction with implant; Procedure: Partial submuscular coverage |
| Breast reconstruction without ADM | Active comparator | Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage. Receives: Procedure: Skin or nipple sparing mastectomy; Procedure: Reconstruction with implant; Procedure: Total submuscular coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary.
Follow-up time after primary surgery is 24 months.
Measured: 24 months
Secondary outcomes (5)
Aesthetic outcome
To measure aesthetic outcome between the two study groups using a 6- point scale. The evaluation will be done by three independent groups consisting of lay people, professionals (breast/ plastic surgeons) and patient evaluation. The aesthetic evaluation will be based on the pre and postoperative photos.
Measured: 24 months
Complications
To measure any difference between the two study groups in complication rates.
Measured: 24 months
Number of surgical procedures
To compare the total number of surgical procedures (planned or unplanned) between the two study groups).
Measured: 24 months
Cost-Benefit analysis
A cost-benefit analysis comparing the cost for an IBR with implant without ADM, vs. IBR with ADM (Strattice™) during a 24 months follow-up time.
Measured: 24 months
Quality of Life
Measure Quality of Life in both groups, using the EORTC QLQ-C30 (Generic tool), EORTC-BR23 (Breast cancer specific tool), EORTC-BRR (Specific for breast reconstruction).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, LifeCell
- Responsible party
- Principal investigator, Fredrik Lohmander, Karolinska University Hospital
- Investigators
- Fredrik Lohmander, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061527
- Sponsor's protocol ID
- FL/KUH-ADM-LFC-2014
- Status last verified
- Apr 2018
- First submitted
- 11 Feb 2014
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lohmander F, Lagergren J, Johansson H, Roy PG, Brandberg Y, Frisell J. Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127806. doi: 10.1001/jamanetworkopen.2021.27806.
PubMed 34596671Lohmander F, Lagergren J, Johansson H, Roy PG, Frisell J, Brandberg Y. Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial. BJS Open. 2020 Oct;4(5):811-820. doi: 10.1002/bjs5.50324. Epub 2020 Aug 6.
PubMed 32762012
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT02061527
- Acronym / sponsor ID
- FL/KUH-ADM-LFC-2014
- Conditions
- Breast Cancer
- Keywords
- ADM, Strattice, Breast reconstruction, Immediate breast reconstruction, IBR, Acellular dermal matrix, Biological mesh, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, LifeCell
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Feb 2014 (estimated)
- 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.
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
Detailed description
OBJECTIVES: To evaluate the outcome of immediate breast reconstruction with Acellular Dermal Matrix (Strattice™), measuring safety, effectiveness, and costs. The primary outcome measure is number of unplanned surgical procedures.
STUDY DESIGN: A prospective randomized multicenter trial. One hundred and twenty patients with breast cancer will be enrolled into the study. Study duration will be two years from time of primary cancer surgery.
TRIAL DESIGN This is a randomized controlled multicenter trial, comparing IBR without (group A) and with (group B) the use of ADM. Participants eligible for the study are patients with breast cancer, planned for mastectomy, who wishes IBR with implants. Each participant is individually randomized to either be reconstructed using implants with total submuscular coverage (A) or reconstruction with ADM and partial muscle coverage (B).
Method of assigning patients to treatment groups:
After signing and dating the informed consent the patient is entered into the study. If all inclusion and none of the exclusion criteria are full filled, the patient will be randomized to group A or group B.
TREATMENT/ INTERVENTION The decision and treatment plan advocating mastectomy is based on multi disciplinary conference (MDT), and the diagnosis of invasive or pre-invasive (in situ) breast cancer is made on triple assessment. If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.
Randomization at enrollment is made with regard to the use of ADM or not, so both expander and direct-to-implant techniques will be utilized in both groups, depending on the quality of skin flaps at time of surgery.
RANDOMIZATION TYPE Patients will be allocated to treatment according to permuted block technique. The actual randomization will be performed using computer based system located at Regional Cancer Center (RCC) within Karolinska Institutet. In this system inclusion and exclusion criteria will be automatically checked before patients are randomized to treatment. The randomization process will be stratified for the participating units.
STATISTICAL METHODS The main endpoint to be analyzed is the proportion of unplanned reoperations after the initial breast reconstruction. The difference in proportions between the two groups will be presented as a difference in proportion together with a 95% confidence interval. Differences will be tested using Fishers Exact Test. Logistic regression will be used to take into account possible confounding factors.
STUDY MANAGEMENT Data recording: The investigators will ensure that all data from patient visits are entered promptly in ink, in the case report forms (CRF). The principal investigator must sign the final CRF page to attest to the accuracy and completeness of the data. The data from the CRFs are then transferred to a database.
Monitoring and audit: At periods not exceeding 3 months, centers will be contacted to discuss the progress of the trial, with the purpose to verify CRF data against source records for accuracy of data recording and collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction with ADM | Experimental | Procedure: Reconstruction with ADM., Procedure: Skin or nipple sparing mastectomy, Procedure: Reconstruction with implant, Procedure: Partial submuscular coverageImplant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage. |
| Breast reconstruction without ADM | Active comparator | Procedure: Skin or nipple sparing mastectomy, Procedure: Reconstruction with implant, Procedure: Total submuscular coverageBreast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral)
- Patient agrees to participate in study and to sign an informed consent form
- Able and willing to return for all scheduled and required study visits
Key exclusion criteria (9 listed)
- Is a smoker (patient having quit at least 4 weeks prior surgery can be included)
- BMI <18 or > 30
- Previous radiation therapy to the region at any time
- Insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies
- Predicted implant size <200 or >600 ml per investigator assessment
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 |
|---|---|---|
| Reconstruction with ADM.Also: Strattice, ADM, Implant, Immediate breast reconstructionIf the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM. | Procedure or surgery | Breast reconstruction with ADM |
| Skin or nipple sparing mastectomyAlso: Mastectomy, Skin sparing mastectomy, Nipple sparing mastectomy, Acellular dermal matrixMastectomy for invasive or pre-invasive breast cancer | Procedure or surgery | Breast reconstruction with ADM, Breast reconstruction without ADM |
| Reconstruction with implantAlso: Implant, Mastectomy, Acellular dermal matrix, Direct-to-implantImmediate breast reconstruction with implant | Procedure or surgery | Breast reconstruction with ADM, Breast reconstruction without ADM |
| Total submuscular coverageImplant based breast reconstruction with total submuscular coverage | Procedure or surgery | Breast reconstruction without ADM |
| Partial submuscular coverageImplant based breast reconstruction with partial submuscular coverage | Procedure or surgery | Breast reconstruction with ADM |
Primary outcome
The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary.
Time frame: 24 months
Follow-up time after primary surgery is 24 months.
5 secondary outcomes
Aesthetic outcome
Time frame: 24 months
Complications
Time frame: 24 months
Number of surgical procedures
Time frame: 24 months
Cost-Benefit analysis
Time frame: 24 months
Quality of Life
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 34596671Lohmander F, Lagergren J, Johansson H, Roy PG, Brandberg Y, Frisell J. Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127806. doi: 10.1001/jamanetworkopen.2021.27806.
- Derived from this study: PubMed 32762012Lohmander F, Lagergren J, Johansson H, Roy PG, Frisell J, Brandberg Y. Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial. BJS Open. 2020 Oct;4(5):811-820. doi: 10.1002/bjs5.50324. Epub 2020 Aug 6.
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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.
Fredrik Lohmander, MD principal investigator
Karolinska Institutet
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction with ADM., Skin or nipple sparing mastectomy and Reconstruction with implant in people with Breast Cancer, run by Karolinska University Hospital at 5 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary. (time frame: 24 months). 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 NCT02061527, which also lists 2 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 24 Apr 2018; AzTrials last refreshed its copy on 26 Oct 2026.