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
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);
Stage IV (metastatic) breast cancer;
No prior radiotherapy post-mastectomy;
History of ipsilateral chest wall/axillary radiation therapy;
Immunodeficiency, poorly controlled diabetes (HbA1c >7%), or active tobacco use;
Treatment-naïve women with unilateral primary breast cancer (clinical stage cT1-3N0-3M0) scheduled for immediate prepectoral direct-to-implant reconstruction OR tissue expander/implant two-stage reconstruction, followed by adjuvant radiotherapy.
Cohort
Prospective
Breast Reconstruction Surgery
Procedure/SurgeryBreast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander/implant reconstruction) with postoperative adjuvant radiotherapy
BREAST-Q (Breast Reconstruction Module) Scores
This trial collects patient-reported outcomes through four domains of the BREAST-Q Breast Reconstruction Module: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Sexual Well-being. Scores are assessed preoperatively and at 12 months postoperatively. The BREAST-Q score at 12 months post-surgery serves as the primary endpoint.
Breast Reconstruction Failure Rate
Breast Reconstruction Failure Rate: Defined as the proportion of patients requiring implant removal due to complications among all patients undergoing breast reconstruction. Implant Removal Due to Complications: Refers to explantation occurring within 12 months postoperatively attributed to any of the following surgery-related complications: Hematoma, Seroma, Flap necrosis, Nipple-areolar complex (NAC) necrosis, Surgical site infection, Wound dehiscence, Implant exposure, Baker grade III/IV capsular contracture, Implant malposition/displacement. Exclusion Criterion: Implant removals requested by patients without objective surgery-related complications (i.e., subjectively motivated explantations) must be documented separately and excluded from failure rate calculations.
Complication Profile:
Includes but not limited to: Hematoma, Poor Wound Healing, Flap Necrosis, Surgical Site Infection, Wound Dehiscence, Fat Grafting-Associated Complications. All complications must be graded according to the Clavien-Dindo Classification System, then systematically assessed and documented.
Physician-Assessed Aesthetic Outcome
Evaluated by surgeons independent of the operating team using the Harris Scale to grade the aesthetic outcome of the reconstructed breast based on standardized patient photographs.
Capsular Contracture Assessment
Evaluated using the Baker Classification System (Spear \& Baker, 1995).
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