Using a patient’s own fat mixed with platelet-rich fibrin to rebuild the breast after conservation surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a fat graft mixed with platelet-rich fibrin (PRF) placed into the breast after tumor removal. Patients undergo liposuction to harvest fat, which is then combined with PRF and calcium chloride to form lipobolus for immediate grafting. The trial follows participants for 12 months with ultrasound, exams, and BREASTQ questionnaires to assess graft retention, safety, and quality of life. The primary outcomes focus on how much graft volume remains after 3 months post-radiation and the procedure’s safety, including breast cancer recurrence signals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Leningrad Regional Clinical Hospital
  Saint Petersburg, Russia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.