Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arm I (Prepectoral), Arm II (Subpectoral)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Breast implants
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
I (Prepectoral)
II (Subpectoral)
Arm Description
Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Patient reported outcome
1) 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)
Rate of capsular contracture (grade 3 or higher) (%) in long term follow up
1) To compare the rate of Grade 3 or higher capsular contracture at 1 year after the end of PMRT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04391296
Brief Title
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Breast implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I (Prepectoral)
Arm Type
Experimental
Arm Description
Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
Arm Title
II (Subpectoral)
Arm Type
Active Comparator
Arm Description
Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.
Intervention Type
Procedure
Intervention Name(s)
Arm I (Prepectoral), Arm II (Subpectoral)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
Description
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.
Time Frame
6 months after the completion of PMRT
Title
Rate of capsular contracture (grade 3 or higher) (%) by 2D shear elastography
Description
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.
Time Frame
6 months after the completion of PMRT
Secondary Outcome Measure Information:
Title
Patient reported outcome
Description
1) 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)
Time Frame
1 year after the completion of PMRT
Title
Rate of capsular contracture (grade 3 or higher) (%) in long term follow up
Description
1) To compare the rate of Grade 3 or higher capsular contracture at 1 year after the end of PMRT
Time Frame
1 year after the completion of PMRT
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.)
12. IPD Sharing Statement
Learn more about this trial
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
We'll reach out to this number within 24 hrs