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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Arm I (Prepectoral), Arm II (Subpectoral)

• Registration Number: NCT04391296
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Status Verified: 2020-06
• Study Start: 2020-06-01
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 114

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I (Prepectoral)	Arm I (Prepectoral), Arm II (Subpectoral)	Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.
II (Subpectoral)	Arm I (Prepectoral), Arm II (Subpectoral)	Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.

Primary Outcome Measures

Name	Time	Method
Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale	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	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.

Secondary Outcome Measures

Name	Time	Method
Rate of capsular contracture (grade 3 or higher) (%) in long term follow up	1 year after the completion of PMRT	1) To compare the rate of Grade 3 or higher capsular contracture at 1 year after the end of PMRT
Patient reported outcome	1 year after the completion of PMRT	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)