Breast CancerPhase 3PreBRecNCT02831426
Pre-pectoral Breast Reconstruction PART 2
A Phase 3 study testing Two-stage with Acellular Dermal Matrix (CELLIS® Breast) and Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) in people with Breast Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Two-stage with Acellular Dermal Matrix (CELLIS® Breast) and Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Dec 2020
- Phase
- Phase 3
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM, nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM), both prophylactic and therapeutic.
- Included patients baseline characteristics will be:
- age 18-80 years old
- BMI between 18.5 and 35.
- Former smokers (up until 3 weeks before surgery)
- hypertension at oral medications
Show all 9Show fewer
- diabetes
- previous breast surgery
- previous breast and chest wall radiation therapy will be allowed.
Who cannot join
- T4 and metastatic breast cancers
- obese patients (BMI over 35)
- currently smoking patients (within 3 weeks before surgery)
- refusal to sign the consent
- severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Breast Surgery Unit, Guy's and St Thomas' Hospital NHS Trust
London, SE1 9RT
Tibor Kovacs, MD, 00447879408272, tibor.kovacs@gstt.nhs.uk
Ashutosh Kothari, MD
About this study
Official title: Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.
Read the detailed description
This phase III randomized clinical trial will be investigating the Two-stage, using Tissue Expander (TE) pre-pectoral reconstructions.
The trial will comprise two arms:
PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING
- Conditions
- Breast Cancer
- Being tested
- Two-stage with Acellular Dermal Matrix (CELLIS® Breast), Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-stage with Acellular Dermal Matrix (CELLIS® Breast)Device
Also called Tissue Expander two-stage reconstruction with ADM, Tissue Expander / Implant exchange, Fat grafting
After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by an ADM (CELLIS® Breast, MECCELLIS BIOTECH, 40 rue Chef de Baie, 17000, La Rochelle FRANCE) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.
Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)Device
Also called Tissue Expander two-stage reconstruction with TCPM, Tissue Expander / Implant exchange, Fat grafting
After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by a Titanium Coated Polypropylene Mesh (TiLOOOP® Bra, pfm medical, ag Wankelstraße 60 ,50996 Köln GERMANY) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.
| Study group | Role | What they receive |
|---|---|---|
| ADM two-stage reconstruction | Active comparator | Two-stage with Acellular Dermal Matrix (CELLIS® Breast). Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM Receives: Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast) |
| TCPM two-stage reconstruction | Experimental | Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra). Tissue Expander B, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by TCPM Receives: Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate in percentage of surgical complications
Surgical outcomes will be evaluated considering the rate in percentage of cases affected by the following complications among total number:
surgical site infection (any infection requiring an antibiotic therapy, either oral or intravenous), wound dehiscence, seroma (any fluid collection requiring aspiration for more than a month from mastectomy), nipple/skin necrosis (either partial or complete), hematoma, red breast syndrome, with their reintervention rate. Rates will be compared between the two groups
Measured: up to 6 months
Rate in percentage of technique failure
The failure rate, as percentage, will be compared between the two arms:
failure will be the prosthesis (implant or TE) loss rate (reintervention with prosthesis removal) among overall number of prostheses implanted.
Measured: up to 6 months
Secondary outcomes (3)
Objective quality of life assessment with Baker scale for capsular contracture
Long-term outcomes, after two years from mastectomy and at least 3 months from TE/implant exchange, in quality of life will entail first of all an objective assessment: such evaluation will include the capsular contracture rate, with the assessment of the reintervention rate for amelioration or for a reconstructive strategy change. Among these objective evaluations, any possible short-term complications after second-stage procedure will be investigated.
Measured: at 2 years from mastectomy
Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale for scoring
A third party objective evaluation will be carried out by a group of a surgeon, a nurse and a lay person from a different center from that one where every single case was performed. This third party evaluation will assess the cosmetic outcome based on medical photographic files, giving a score for each patient. Scores from the two arms will be compared.
Measured: at 2 years from mastectomy
Subjective quality of life assessment with BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved)
After 2 years from mastectomy and at least 3 months from TE/implant exchange a subjective evaluation will be carried out with BREAST-Q score (scores from the two arms will be transformed in 100 scale, summed and compared as median)
Measured: at 2 years from mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kovacs, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831426
- Sponsor's protocol ID
- RCTBU022016
- Acronym
- PreBRec
- Status last verified
- Sep 2016
- First submitted
- 29 Jun 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02831426
- Acronym / sponsor ID
- PreBRec / RCTBU022016
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jul 2016 (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.
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.
Detailed description
This phase III randomized clinical trial will be investigating the Two-stage, using Tissue Expander (TE) pre-pectoral reconstructions.
The trial will comprise two arms:
PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADM two-stage reconstruction | Active comparator | Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast)Two-stage with Acellular Dermal Matrix (CELLIS® Breast). Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM |
| TCPM two-stage reconstruction | Experimental | Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra). Tissue Expander B, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by TCPM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM, nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM), both prophylactic and therapeutic.
- age 18-80 years old
- BMI between 18.5 and 35.
- Former smokers (up until 3 weeks before surgery)
- hypertension at oral medications
Key exclusion criteria (5 listed)
- T4 and metastatic breast cancers
- obese patients (BMI over 35)
- currently smoking patients (within 3 weeks before surgery)
- refusal to sign the consent
- severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
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 |
|---|---|---|
| Two-stage with Acellular Dermal Matrix (CELLIS® Breast)Also: Tissue Expander two-stage reconstruction with ADM, Tissue Expander / Implant exchange, Fat graftingAfter mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by an ADM (CELLIS® Breast, MECCELLIS BIOTECH, 40 rue Chef de Baie, 17000, La Rochelle FRANCE) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue. | Device | ADM two-stage reconstruction |
| Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)Also: Tissue Expander two-stage reconstruction with TCPM, Tissue Expander / Implant exchange, Fat graftingAfter mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by a Titanium Coated Polypropylene Mesh (TiLOOOP® Bra, pfm medical, ag Wankelstraße 60 ,50996 Köln GERMANY) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue. | Device | TCPM two-stage reconstruction |
Primary outcome
Rate in percentage of surgical complications
Time frame: up to 6 months
Surgical outcomes will be evaluated considering the rate in percentage of cases affected by the following complications among total number: surgical site infection (any infection requiring an antibiotic therapy, either oral or intravenous), wound dehiscence, seroma (any fluid collection requiring aspiration for more than a month from mastectomy), nipple/skin necrosis (either partial or complete), hematoma, red breast syndrome, with their reintervention rate. Rates will be compared between the two groups
Rate in percentage of technique failure
Time frame: up to 6 months
The failure rate, as percentage, will be compared between the two arms: failure will be the prosthesis (implant or TE) loss rate (reintervention with prosthesis removal) among overall number of prostheses implanted.
3 secondary outcomes
Objective quality of life assessment with Baker scale for capsular contracture
Time frame: at 2 years from mastectomy
Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale for scoring
Time frame: at 2 years from mastectomy
Subjective quality of life assessment with BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved)
Time frame: at 2 years from mastectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Two-stage with Acellular Dermal Matrix (CELLIS® Breast) and Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) in people with Breast Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tibor Kovacs, PhD, FRCS (07879408272, tiborkovacsdr@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate in percentage of surgical complications (time frame: up to 6 months). 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?
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 Oct 2016.