About this trial
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 criteria
Qualifiers
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+).
Disqualifiers
Male gender.
ECOG ≥ 1.
Multifocal or multicentric tumor.
Grade G3.
Trial design
Treatments tested in this trial
- Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)