Recruiting

AFT: Introduction of a Full Breast Reconstructive Method

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

ClinicalTrials.gov IDNCT04261829

PhaseNot Applicable

Enrollment350

SponsorMaastricht University Medical Center

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Reconstructive Surgery, Breast Reconstruction

About this study

Interventions

Procedure: Autologous Fat Transfer — Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Primary outcomes

Breast-related Quality of life (2 years)

Eligibility information

Inclusion Criteria: * Female gender * Age of 18 years and older * History or in candidate for a mastectomy procedure in the near future * Patients undergoing preventive mastectomy * Patients' choice to undergo a breast reconstruction * Wanting to participate in this study * Patient is able to wear the external expansion device Exclusion Criteria: * Active smoker or a history of smoking 4 weeks prior to surgery * Current substance abuse * History of lidocaine allergy * History of silicone allergy * 4 weeks or less after chemotherapy * History of radiation therapy in the breast region * Oncological treatment includes radiotherapy after mastectomy * Kidney disease * Steroid dependent asthma (daily or weekly) or other diseases * Immune-suppressed or compromised disease * Uncontrolled diabetes * BMI\>30 * Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C * Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction * The treating plastic surgeon has strong doubts on the patient's treatment compliance

Study locations

Maastricht University Medical Center+, Maastricht, Limburg 6229 HX Netherlands
Viecuri Venlo, Venlo, Limburg Netherlands
Amsterdam University Medical Center (VUMC), Amsterdam, Netherlands
Rijnstate, Arnhem, Netherlands
Alexander Monro, Bilthoven, Bilthoven, Netherlands
Amphia, Breda, Netherlands
Ziekenhuis groep Twente (ZGT), Hengelo, Netherlands
Medical Center Leeuwarden, Leeuwarden, Netherlands

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.