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Recruiting NCT04261829

AFT: Introduction of a Full Breast Reconstructive Method

— Observational Breast Cancer Reconstructive Surgery Breast Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Fat Transfer.
Who it may be relevant to
Registry conditions: Breast Cancer, Reconstructive Surgery, Breast Reconstruction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

Overview

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.

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 outcome measures

  • Breast-related Quality of life [Time frame: 2 years]
Secondary outcome measures (4)
  • Aesthetic result [Time frame: 2 years]
  • Complications [Time frame: 2 years]
  • Oncological safety [Time frame: 5 years]
  • Cost-effectiveness [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 8 centers
  • Maastricht University Medical Center+ — Maastricht
  • Viecuri Venlo — Venlo
  • Amsterdam University Medical Center (VUMC) — Amsterdam
  • Rijnstate — Arnhem
  • Alexander Monro, Bilthoven — Bilthoven
  • Amphia — Breda
  • Ziekenhuis groep Twente (ZGT) — Hengelo
  • Medical Center Leeuwarden — Leeuwarden

Publications

  • van der Venne WBW, Goeree KS, Wederfoort JLM, Hommes JE, van Kuijk SMJ, Heuts EM, Piatkowski de Grzymala AA, Moues CM; BREAST-II trial investigators. Evaluation of the BREAST-II Trial for Total Breast Reconstruction Solely Using Autologous Fat Transfer: 1-Year Follow-Up. Plast Reconstr Surg. 2026 Jan 22. doi: 10.1097/PRS.0000000000012742. Online ahead of print. PMID 41568954
  • Rijkx M, Saelmans A, Hommes J, Brandts L, De Bruijn D, Piatkowski A, Heuts E; Breast Reconstruction With External Preexpansion & autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. The Learning Curve of Total Breast Reconstruction With Autologous Fat Transfer. Ann Plast Surg. 2024 Oct 1;93(4):516-526. doi: 10.1097/SAP.0000000000004036. Epub 2024 Jul 15. PMID 39016317

Identifiers

NCT: NCT04261829 · NL72808.068.20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗