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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
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Breast implants

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age over 19 years old
  2. Histologically confirmed diagnosis of unilateral breast cancer
  3. Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication
  4. Patient undergoing immediate implant based breast reconstruction

Exclusion Criteria:

  1. 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)
  2. Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy
  3. History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.
  4. 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

    First Posted
    May 3, 2020
    Last Updated
    June 3, 2020
    Sponsor
    Gangnam Severance Hospital
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    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

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    Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial

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