Breast CancerNCT04391296
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
A study testing Arm I (Prepectoral), Arm II (Subpectoral) in people with Breast Cancer, run by Gangnam Severance Hospital.
Trial summary
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm I (Prepectoral), Arm II (Subpectoral)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Jun 2025
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 19 years old
- Histologically confirmed diagnosis of unilateral breast cancer
- Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication
- Patient undergoing immediate implant based breast reconstruction
Who cannot join
- Underlying medical condition: for example, (AST or ALT >100U/L, inadequate renal function; eGFR < 30ml/min, congestive heart failure; New York Heart Association III-IV)
- Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy
- History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.
- Not able to provide informed consent (Illiterate, foreigners, etc.)
About this study
Official title: Prospective Randomized Control Study About the Effect of Postmastectomy Radiation Therapy on Capsular Contracture in Patients With Prepectoral or Subpectoral Implant-based Breast Reconstruction: PREPER Trial
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in lower risk of capsular contracture after postmastectomy radiation therapy(PMRT) compared with acellular dermal matrix(ADM)-assisted implant-based breast reconstruction with subpectoral implant placement.
Read the detailed description
OUTLINE: This is a single center randomized clinical trial. Participant recruitment and enrollment will occur at Gangnam Severance Hospital Breast Cancer Center for 4 years, followed by one year of follow up data collection and analysis.
Arm I (Prepectoral): immediate ADM-assisted implant-based breast reconstruction with prepectoral implant placement.
Arm II (Subpectoral): immediate ADM-assisted implant-based breast reconstruction with subpectoral implant placement.
This clinical study is aimed at patients who have been diagnosed with breast cancer and who have undergone a total mastectomy for the therapeutic indication, and who are planning to undergo implant based reconstruction and postmastectomy radiotherapy.
It will be carried out prospectively in a single institution, and the study will be divided into two groups, subpectoral implant and prepectoral implant, according to the reconstruction method.
A total of 96 patients or 48 patients per arm will be recruited. Randomization will be accomplished using randomly permuted blocks, and randomization will be stratified on the basis of reconstruction method. (tissue expander insertion or direct-to-implant)
After completion of study treatment, patients are followed for 1 year for observation of capsular contracture and patient reported outcomes.
- Conditions
- Breast Cancer
- Being tested
- Arm I (Prepectoral), Arm II (Subpectoral)
- Keywords
- Breast Cancer, Breast implants
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Prepectoral), Arm II (Subpectoral)Procedure or surgery
Arm I (Prepectoral)De-epithelialized skin flaps are made from the inferior pole of breast skin and soft tissue. The implant pocket is shaped by fixing a sufficiently large amount of ADM to the medial surface of the mastectomy pocket, the upper edge of the pectoralis major muscle and the de-epithelial skin flap. The implant is located in the prepectoral mastectomy pocket and the ADM anchored to the chest wall, serratus fascia, and de-epithelial skin flaps. The pectoralis major muscle is located in the anatomical location behind the ADM.
Arm II (Subpectoral)The pectoralis major muscle is dissected from the thorax to create sufficient space for the implant to be placed behind the pectoralis major muscle. Implant pockets are made by suturing the lower part of the elevated pectoralis major muscle to the top of the de-epithelial skin flap and the ADM patch to the skin flap, the pectoralis major muscle, and the lateral thoracic fascia.
| Study group | Role | What they receive |
|---|---|---|
| I (Prepectoral) | Experimental | Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. Receives: Procedure: Arm I (Prepectoral), Arm II (Subpectoral) |
| II (Subpectoral) | Active comparator | Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement. Receives: Procedure: Arm I (Prepectoral), Arm II (Subpectoral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
To compare the frequency of grade 3 or higher contracture development analyzed by using Baker's scale at 6 months after the completion of PMRT.
Measured: 6 months after the completion of PMRT
Rate of capsular contracture (grade 3 or higher) (%) by 2D shear elastography
To compare the frequency of grade 3 or higher contracture development analyzed by using 2D shear-wave elastography at 6 months after the completion of PMRT.
Measured: 6 months after the completion of PMRT
Secondary outcomes (2)
Patient reported outcome
- To compare the patient reported outcome (PRO) using Breast Q questionnaire (Reconstruction module, each domain has the scale ranges from 0 to 100, higher the better patient reported outcome)
Measured: 1 year after the completion of PMRT
Rate of capsular contracture (grade 3 or higher) (%) in long term follow up
- To compare the rate of Grade 3 or higher capsular contracture at 1 year after the end of PMRT
Measured: 1 year after the completion of PMRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391296
- Sponsor's protocol ID
- 2019-0837-002
- Status last verified
- Jun 2020
- First submitted
- 3 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Control Study About the Effect of Postmastectomy Radiation Therapy on Capsular Contracture in Patients With Prepectoral or Subpectoral Implant-based Breast Reconstruction: PREPER Trial
- ClinicalTrials.gov ID
- NCT04391296
- Acronym / sponsor ID
- 2019-0837-002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 May 2020 (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.
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in lower risk of capsular contracture after postmastectomy radiation therapy(PMRT) compared with acellular dermal matrix(ADM)-assisted implant-based breast reconstruction with subpectoral implant placement.
Detailed description
OUTLINE: This is a single center randomized clinical trial. Participant recruitment and enrollment will occur at Gangnam Severance Hospital Breast Cancer Center for 4 years, followed by one year of follow up data collection and analysis.
Arm I (Prepectoral): immediate ADM-assisted implant-based breast reconstruction with prepectoral implant placement.
Arm II (Subpectoral): immediate ADM-assisted implant-based breast reconstruction with subpectoral implant placement.
This clinical study is aimed at patients who have been diagnosed with breast cancer and who have undergone a total mastectomy for the therapeutic indication, and who are planning to undergo implant based reconstruction and postmastectomy radiotherapy.
It will be carried out prospectively in a single institution, and the study will be divided into two groups, subpectoral implant and prepectoral implant, according to the reconstruction method.
A total of 96 patients or 48 patients per arm will be recruited. Randomization will be accomplished using randomly permuted blocks, and randomization will be stratified on the basis of reconstruction method. (tissue expander insertion or direct-to-implant)
After completion of study treatment, patients are followed for 1 year for observation of capsular contracture and patient reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I (Prepectoral) | Experimental | Procedure: Arm I (Prepectoral), Arm II (Subpectoral)Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. |
| II (Subpectoral) | Active comparator | Procedure: Arm I (Prepectoral), Arm II (Subpectoral)Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 19 years old
- Histologically confirmed diagnosis of unilateral breast cancer
- Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication
- Patient undergoing immediate implant based breast reconstruction
Key exclusion criteria (4 listed)
- Underlying medical condition: for example, (AST or ALT >100U/L, inadequate renal function; eGFR < 30ml/min, congestive heart failure; New York Heart Association III-IV)
- Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy
- History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.
- Not able to provide informed consent (Illiterate, foreigners, etc.)
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 |
|---|---|---|
| Arm I (Prepectoral), Arm II (Subpectoral)Arm I (Prepectoral)De-epithelialized skin flaps are made from the inferior pole of breast skin and soft tissue. The implant pocket is shaped by fixing a sufficiently large amount of ADM to the medial surface of the mastectomy pocket, the upper edge of the pectoralis major muscle and the de-epithelial skin flap. The implant is located in the prepectoral mastectomy pocket and the ADM anchored to the chest wall, serratus fascia, and de-epithelial skin flaps. The pectoralis major muscle is located in the anatomical location behind the ADM. Arm II (Subpectoral)The pectoralis major muscle is dissected from the thorax to create sufficient space for the implant to be placed behind the pectoralis major muscle. Implant pockets are made by suturing the lower part of the elevated pectoralis major muscle to the top of the de-epithelial skin flap and the ADM patch to the skin flap, the pectoralis major muscle, and the lateral thoracic fascia. | Procedure or surgery | I (Prepectoral), II (Subpectoral) |
Primary outcome
Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
Time frame: 6 months after the completion of PMRT
To compare the frequency of grade 3 or higher contracture development analyzed by using Baker's scale at 6 months after the completion of PMRT.
Rate of capsular contracture (grade 3 or higher) (%) by 2D shear elastography
Time frame: 6 months after the completion of PMRT
To compare the frequency of grade 3 or higher contracture development analyzed by using 2D shear-wave elastography at 6 months after the completion of PMRT.
2 secondary outcomes
Patient reported outcome
Time frame: 1 year after the completion of PMRT
Rate of capsular contracture (grade 3 or higher) (%) in long term follow up
Time frame: 1 year after the completion of PMRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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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 Arm I (Prepectoral), Arm II (Subpectoral) in people with Breast Cancer, run by Gangnam Severance Hospital.
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 4 inclusion and 4 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 5 Jun 2020. 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?
Results are not available in the source record.
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?
Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale (time frame: 6 months after the completion of PMRT). 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 5 Jun 2020.