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+).
Male gender.
ECOG ≥ 1.
Multifocal or multicentric tumor.
Grade G3.
Single group
Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
Procedure/SurgeryThe intervention is a single surgical procedure using a "lipobolus" - a modified fat graft made from the participant's own tissues to restore breast shape after cancer surgery. How it is prepared during surgery: About 200 mL of fat is harvested from the participant's belly using liposuction. Separately, 60 mL of blood is drawn and spun in a centrifuge to obtain platelet-rich plasma (PRP). The fat, PRP, and calcium chloride are mixed. Calcium chloride activates the PRP, forming a thick, gel-like fibrin scaffold that traps the fat fragments into a single, stable block. How it is used: The lipobolus is placed directly into the cavity left after breast-conserving cancer surgery. This allows for immediate volume restoration in one operation. What makes it different: Standard fat grafting uses fat alone and often requires 2-3 procedures due to unpredictable abs
Percentage of Lipobolus Volume Retention at 3 Months Post-Radiotherapy
Volume of the lipobolus that remains viable and engrafted, measured as a percentage of the originally implanted volume. The volume is assessed by breast ultrasound (US) performed 3 months after completion of adjuvant external beam radiotherapy (EBRT). The percentage is calculated as (volume at 3 months post-EBRT / immediate post-operative volume) × 100.
Patient Satisfaction with Aesthetic Results Measured by BREAST-Q
Change in patient-reported satisfaction and psychosocial well-being assessed using the validated BREAST-Q questionnaire. Two modules are used: (1) Satisfaction with Breasts module, and (2) Psychosocial Well-being module. Higher scores indicate better satisfaction and well-being.
Frequency of Locoregional Recurrence and Distant Metastasis
The cumulative incidence of locoregional recurrence (recurrence of cancer in the ipsilateral breast, chest wall, or regional lymph nodes) and distant metastasis (spread of cancer to distant organs) during the observation period. Events are confirmed by imaging (mammography, ultrasound, MRI, or CT) and/or biopsy as clinically indicated.
Dynamic Changes in Lipobolus Volume Assessed by Ultrasound
Change in lipobolus volume over time measured by breast ultrasound. Volume is calculated at each time point and compared to the immediate post-operative volume. Data are used to assess the pattern and rate of graft resorption or stability during the first year after surgery.
Type and Frequency of Complications
The incidence of specific complications occurring after the lipobolus procedure and after radiotherapy. Complications assessed include: oil cysts, fat necrosis, seroma, hematoma, and infection. Events are documented by clinical examination and ultrasound imaging and graded according to CTCAE v5.0 where applicable.
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