Clinical trial NCT04391296: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast implants
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 114
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Rate of capsular contracture (grade 3 or higher) (%) by Baker's scale
timeFrame: 6 months after the completion of PMRT
measure: Rate of capsular contracture (grade 3 or higher) (%) by 2D shear elastography
timeFrame: 6 months after the completion of PMRT
Secondary outcomes:
measure: Patient reported outcome
timeFrame: 1 year after the completion of PMRT
measure: Rate of capsular contracture (grade 3 or higher) (%) in long term follow up
timeFrame: 1 year after the completion of PMRT
Other outcomes:
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