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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorHenan Cancer Hospital

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

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators