Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Tw… (NCT07037576) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
China104 participantsStarted 2025-05-20
Plain-language summary
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. women aged 18 to 70；
✓. Newly diagnosed breast cancer patients showing no evidence of distant metastasis on clinical examination and diagnostic workup；
✓. adjuvant radiotherapy is required;
✓. Patients scheduled to undergo nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral implant-based reconstruction (via open, endoscopic, or robotic approach) require adjuvant radiotherapy AFTER permanent implant placement; OR Patients scheduled for NSM/SSM with two-stage tissue expander/implant reconstruction (with expander placement in either submuscular or prepectoral plane) receive radiotherapy WITH the tissue expander in situ, followed by exchange for permanent implant ≥6 months post-radiotherapy (expander position: submuscular/prepectoral acceptable; surgical approach: open/endoscopic/robotic acceptable);
✓. Patients are eligible regardless of whether mesh is used in the reconstruction surgery;
✓. Patients with severe breast ptosis are eligible;
✓. During the study observation period, lipofilling is permitted on the affected breast and symmetrization procedures on the contralateral breast in both cohorts;
✓. ECOG performance status 0-1;
Exclusion criteria
✕. Stage IV (metastatic) breast cancer;
✕. No prior radiotherapy post-mastectomy;
✕
What they're measuring
1
BREAST-Q (Breast Reconstruction Module) Scores
Timeframe: Preoperatively and at 1 Year Postoperatively