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)

Summary

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.

Conditions5

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