OncoMatch/Clinical Trials/NCT07658170
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)
Is NCT07658170 recruiting? Yes, currently enrolling (Jul 2026). This NA trial studies non-drug interventions for breast cancer.
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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
Estrogen receptor positivity (ER+)
Excluded: HER2 (ERBB2) overexpression
HER2-positive tumor with uncontrolled disease
Disease stage
Required: Stage CTIS (other)
Excluded: Stage CT3 OR HIGHER
Grade: G1, G2 (G)
Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition). Tumor grade G1 or G2.
Performance status
ECOG 0–0(Fully active)
Demographics
Prior therapy
Cannot have received: neoadjuvant chemotherapy
Prior neoadjuvant chemotherapy
Cannot have received: neoadjuvant hormonal therapy
Prior neoadjuvant hormonal therapy
Cannot have received: radiation therapy to the breast
Prior radiation therapy to the breast
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07658170 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neoadjuvant chemotherapy, neoadjuvant hormonal therapy, radiation therapy to the breast disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Are patients with ERBB2 alterations eligible?
No. ERBB2 overexpression is an exclusion criterion.
What disease stage is eligible?
Stage CTIS is required.
Is there an age limit?
Yes. Patients must be 69 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages