Overview
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
Eligibility
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.
