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)

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

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Male gender.
• ECOG ≥ 1.
• Multifocal or multicentric tumor.
• Grade G3.
• Triple-negative or HER2-positive tumor with uncontrolled disease.
• Stage cT3 or higher or distant metastases (M1).
• Inflammatory breast cancer.
• Prior neoadjuvant chemotherapy or hormonal therapy.
• Prior radiation therapy to the breast.
• Presence of blood coagulation disorders (coagulopathy, thrombocytopathy, thrombocytopenia < 100 × 10⁹/L).
• Taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued.
• Presence of active infectious diseases.
• Acute autoimmune diseases.
• Decompensated comorbidities (diabetes mellitus, cardiovascular diseases, etc.).
• Body mass index (BMI) < 18.5 kg/m² (insufficient adipose tissue volume for liposuction).
• Pregnancy or lactation.
• Mental illnesses that prevent informed consent.
• Known allergy to local anesthetics or sodium citrate.