About this trial
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
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Breast Reconstruction Surgery