Mastectomy and Breast ReconstructionESSBRNCT01910298
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
A study testing Breast Reconstruction, Direct to Implant (DTI) with Strattice™ and Two Stage Breast Reconstruction in people with Mastectomy and Breast Reconstruction, run by LifeCell at 18 sites in 3 countries.
Trial summary
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy and Breast Reconstruction
- What is being tested?
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™ and Two Stage Breast Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 29 Jul 2013to 23 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female 18 years or older
- A candidate for both arms of the study involving immediate breast reconstruction post-skin sparing mastectomy (unilateral or bilateral) DTI with the use of Strattice™ Reconstructive Tissue Matrix (TM), 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue)
- An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2
- Estimated life expectancy > 3 years
- Able and willing to return for all scheduled and required study visits
- Able to provide written informed consent for study participation
Who cannot join
- Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results
- Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy
- Previous radiation therapy to either breast at any time
- Predicted permanent implant size that is greater than or equal to 500 grams (gms), per Investigator assessment
- Body mass index (BMI) <17 or > 30
- Co-morbid factors which predispose to postoperative infection, e.g. diabetes, collagen vascular disease, chronic steroid (except inhalers)/immunosuppressant use, immune deficiency, or co-existent infection
Show all 16Show fewer
- Pregnant or lactating
- 3rd degree ptosis
- Prior breast surgery including breast reduction, augmentation, mastopexy, quadrectomy, and partial mastectomy with reduction of the skin envelope
- Prior use of a device (mesh or matrix) in the Breast
- Concomitant unrelated condition of breast/chest wall/skin that, as determined by the investigator, could adversely affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
- Planned autologous tissue flap in addition to prosthetic implant
- Use of permanent expander implants such as Becker expanders or the Natrelle™ Permanent expander 150
- Current alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
- Currently enrolled or plans to enroll in another clinical trial unless it is: a registry, a retrospective study, a neo-adjuvant chemotherapy trial (as long as the chemotherapy regimen has been stopped 4 weeks prior to mastectomy), or a hormone/anti-hormonal therapy trial
- Any of the conditions identified within the labelled contraindications, i.e. sensitivity to porcine derived products or polysorbate 20.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Germany8 sites
Universitätsklinikum Erlangen
Erlangen, 91054
Kliniken Essen-Mitte
Essen, 45131
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Medizinische Hochschule Hannover
Hanover, 30625
Universitäts-Frauenklinik Heidelberg
Heidelberg, 69115
Klinik der Universität München, Campus Innenstadt
Munich, 80337
Klinikum rechts der Isar
Munich, 81675
Asklepios Paulinen Klinik
Wiesbaden, 65197
France5 sites
Institut Bergonie
Bordeaux, 33076
Centre Oscar Lambret
Lille, 59000
Institut du Cancer de Montpellier Val d'Aurelle
Montpellier, 34298
L'Institut du Sein- Paris Breast Center
Paris, 75116
Hopital Tenon APHP
Paris
United Kingdom5 sites
St Luke's hospital / Bradford Royal Infirmary (BRI)
Bradford, BD5 0NA
Dorset County Hospital
Dorchester, DT1 2JY
Frimley Park Hospital
Frimley, GU16 7UJ
Wythenshawe Hospital UHSM NHS Foundation Trust
Manchester, M23 9LT
City Hospital
Nottingham, NG5 1PB
About this study
Official title: A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.
Read the detailed description
The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.
Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.
- Conditions
- Mastectomy and Breast Reconstruction
- Being tested
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Keywords
- Breast reconstruction, Breast implant, Breast cancer, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Reconstruction, Direct to Implant (DTI) with Strattice™Procedure or surgery
Two Stage Breast ReconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Breast Reconstruction, Direct to Implant (DTI) with Strattice™ | Active comparator | Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh). Receives: Procedure: Breast Reconstruction, Direct to Implant (DTI) with Strattice™ |
| Two Stage Breast Reconstruction | Active comparator | Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant. Receives: Procedure: Two Stage Breast Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)
ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.
Measured: Up to 12 months post ISS
Secondary outcomes (6)
Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)
Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out.
Measured: Up to 12 months post ISS
Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)
Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade > 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out.
Measured: Up to 24 months ppR
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR
The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast).
Measured: Up to 24 months ppR
Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel
Measured: Baseline up to Month 24
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS
ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.
Measured: Baseline up to 6 months post ISS
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast
Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction.
Measured: Within 24 months ppR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study start29 Jul 2013
- Primary completion31 Aug 2016
- Study completion23 Oct 2017
Why it stopped: The study is being terminated due to no enrollment in over one year in the control arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mastectomy and Breast ReconstructionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Jacobs, Study chair, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910298
- Sponsor's protocol ID
- LFC 2012.06.01
- Acronym
- ESSBR
- Status last verified
- Apr 2019
- First submitted
- 22 Jul 2013
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)
- ClinicalTrials.gov ID
- NCT01910298
- Acronym / sponsor ID
- ESSBR / LFC 2012.06.01
- Conditions
- Mastectomy and Breast Reconstruction
- Keywords
- Breast reconstruction, Breast implant, Breast cancer, Mastectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is being terminated due to no enrollment in over one year in the control arm
- Enrolment
- 131 participants (actual)
- Lead sponsor
- LifeCellIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.
Detailed description
The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.
Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Reconstruction, Direct to Implant (DTI) with Strattice™ | Active comparator | Procedure: Breast Reconstruction, Direct to Implant (DTI) with Strattice™Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh). |
| Two Stage Breast Reconstruction | Active comparator | Procedure: Two Stage Breast ReconstructionParticipants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an 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)
- Female 18 years or older
- A candidate for both arms of the study involving immediate breast reconstruction post-skin sparing mastectomy (unilateral or bilateral) DTI with the use of Strattice™ Reconstructive Tissue Matrix (TM), 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue)
- An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2
- Estimated life expectancy > 3 years
- Able and willing to return for all scheduled and required study visits
Key exclusion criteria (16 listed)
- Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results
- Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy
- Previous radiation therapy to either breast at any time
- Predicted permanent implant size that is greater than or equal to 500 grams (gms), per Investigator assessment
- Body mass index (BMI) <17 or > 30
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 Reconstruction, Direct to Implant (DTI) with Strattice™ | Procedure or surgery | Breast Reconstruction, Direct to Implant (DTI) with Strattice™ |
| Two Stage Breast Reconstruction | Procedure or surgery | Two Stage Breast Reconstruction |
Primary outcome
Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)
Time frame: Up to 12 months post ISS
ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.
6 secondary outcomes
Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)
Time frame: Up to 12 months post ISS
Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)
Time frame: Up to 24 months ppR
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR
Time frame: Up to 24 months ppR
Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel
Time frame: Baseline up to Month 24
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS
Time frame: Baseline up to 6 months post ISS
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast
Time frame: Within 24 months ppR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donna Jacobs study chair
Allergan
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Reconstruction, Direct to Implant (DTI) with Strattice™ and Two Stage Breast Reconstruction in people with Mastectomy and Breast Reconstruction, run by LifeCell at 18 sites in 3 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, France, 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?
Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS) (time frame: Up to 12 months post ISS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2019.