Breast CancerPhase 3PreBRecNCT02830685
Pre-pectoral Breast Reconstruction PART 1
A Phase 3 study testing DTI with Acellular Dermal Matrix (CELLIS® Breast) and DTI 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?
- DTI with Acellular Dermal Matrix (CELLIS® Breast) and DTI 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
- 131 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)
- Prophylactic and therapeutic.
- Included patients baseline characteristics will be:
- Age 18-80 years old
- BMI between 18.5 and 35.
Show all 11Show fewer
- Former smokers (up until 3 weeks before surgery)
- Hypertension at oral medications
- 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 Unit Surgery, 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 DIRECT-TO-IMPLANT (DTI) 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 compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:
the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING
- Conditions
- Breast Cancer
- Being tested
- DTI with Acellular Dermal Matrix (CELLIS® Breast), DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
- Keywords
- pre-pectoral breast reconstruction, subcutaneous 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.
DTI with Acellular Dermal Matrix (CELLIS® Breast)Device
Also called Pre-pectoral Direct-to-implant with ADM, fat grafting
After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.
DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)Device
Also called Pre-pectoral Direct-to-implant with TCPM, fat grafting
After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.
| Study group | Role | What they receive |
|---|---|---|
| Direct-To-Implant A | Active comparator | DTI with Acellular Dermal Matrix (CELLIS® Breast), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of an Acelluar Dermal Matrix (ADM) Receives: Device: DTI with Acellular Dermal Matrix (CELLIS® Breast) |
| Direct-To-Implant B | Experimental | DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of a titanium coated polypropylene mesh Receives: Device: DTI 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 within the first six months from mastectomy and IBBR will be evaluated with the statistical difference in percentage rate of complicated and non complicated patients between the two groups. Complications will be the following:
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, all in percentages.
Measured: up to 6 months
Rate in percentage of technique failure
The failure rate will be assessed considering the statistical difference in percentage rate of removed implants among total number and comparing them between the two arms: in other words the prostheses (implants) loss rate (reinterventions with prosthesis removal).
Measured: up to 6 months
Secondary outcomes (3)
Objective quality of life assessment with Baker scale for capsular contracture
Quality of life outcomes at 2 years from mastectomy and at least 3 months after completion of the reconstructive step included in the protocol (one fat grafting procedure) will entail first of all an objective evaluation: such evaluation will be performed with the the scoring of capsular contracture rate, including assessment of the reintervention rate for amelioration or for a reconstructive strategy change, comparing the two arms.
Measured: at 2 years from mastectomy
Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale scoring
In addition another objective analysis will include a third party objective evaluation, 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. Scores from this ranking will be compared between the two groups.
Measured: at 2 years from mastectomy
Subjective quality of life assessment using the BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved).
Quality of life outcomes at 2 years from mastectomy and at least 3 months after completion of the reconstructive step included in the protocol (one fat grafting procedure) will entail also a subjective evaluation: such evaluation will be carried out using the BREAST-Q questionnaire. Scores will be transformed in a 100 scale and compared as median between the two groups.
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 completionJul 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
- 131 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
- NCT02830685
- Sponsor's protocol ID
- RCTBU012016
- Acronym
- PreBRec
- Status last verified
- Sep 2016
- First submitted
- 28 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 DIRECT-TO-IMPLANT (DTI) Pre-pectoral Implant Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02830685
- Acronym / sponsor ID
- PreBRec / RCTBU012016
- Conditions
- Breast Cancer
- Keywords
- pre-pectoral breast reconstruction, subcutaneous breast reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 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 compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:
the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-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 |
|---|---|---|
| Direct-To-Implant A | Active comparator | Device: DTI with Acellular Dermal Matrix (CELLIS® Breast)DTI with Acellular Dermal Matrix (CELLIS® Breast), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of an Acelluar Dermal Matrix (ADM) |
| Direct-To-Implant B | Experimental | Device: DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of a titanium coated polypropylene mesh |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM
- Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM)
- Prophylactic and therapeutic.
- Age 18-80 years old
- BMI between 18.5 and 35.
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 |
|---|---|---|
| DTI with Acellular Dermal Matrix (CELLIS® Breast)Also: Pre-pectoral Direct-to-implant with ADM, fat graftingAfter conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant. | Device | Direct-To-Implant A |
| DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)Also: Pre-pectoral Direct-to-implant with TCPM, fat graftingAfter conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant. | Device | Direct-To-Implant B |
Primary outcome
Rate in percentage of surgical complications
Time frame: up to 6 months
Surgical outcomes within the first six months from mastectomy and IBBR will be evaluated with the statistical difference in percentage rate of complicated and non complicated patients between the two groups. Complications will be the following: 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, all in percentages.
Rate in percentage of technique failure
Time frame: up to 6 months
The failure rate will be assessed considering the statistical difference in percentage rate of removed implants among total number and comparing them between the two arms: in other words the prostheses (implants) loss rate (reinterventions with prosthesis removal).
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 scoring
Time frame: at 2 years from mastectomy
Subjective quality of life assessment using the 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.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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 DTI with Acellular Dermal Matrix (CELLIS® Breast) and DTI 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 11 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 Kovac, 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.