Status:
UNKNOWN
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
NA
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 an...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04391296
Start Date
June 1 2020
End Date
June 30 2025
Last Update
June 5 2020
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