Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)
The goal of this clinical trial is to learn if a special type of fat graft, made by mixing a person's own fat with platelet-rich fibrin (PRF), works to fix breast shape defects after cancer surgery. PRF is a substance made from a person's own blood that is rich in growth factors, which may help the graft survive better. The main questions it aims to answer are: What percentage of the fat graft's volume remains in place 3 months after radiation therapy? What is the safety of this procedure, including its side effects and any impact on cancer returning? Participants will: * Undergo standard breast-conserving surgery to remove the tumor * Have liposuction (fat removal) from their own belly or thighs * Receive a lipobolus (their own fat mixed with PRF) placed into the breast defect during the same surgery * Follow up for 12 months with ultrasound scans, physical exams, and questionnaires (BREASTQ) about their satisfaction and quality of life
• Histologically verified breast cancer (BC).
• Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition).
• Tumor grade G1 or G2.
• Estrogen receptor positivity (ER+).
• ECOG performance status = 0.
• Primary tumor size up to 2 cm, based solely on preoperative examination data (mammography, ultrasound, MRI).
• Indications for breast-conserving surgery (BCS) with a breast resection extent determined by a multidisciplinary oncology board.
• Submission of an informed voluntary consent (IVC) regarding participation in the study.
• Ability to understand and comply with the requirements of the study protocol.