Clinical trial · Observational
AFT: Introduction of a Full Breast Reconstructive Method
Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
NCT04261829CI-TRIAL-00052967BREAST-IIrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Reconstructive Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Fat Transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Autologous Fat Transfer
- interventionNames
- Procedure: Autologous Fat Transfer
Primary outcomes (1)
- measure
- Breast-related Quality of life
- timeFrame
- 2 years
- description
- Measured by the BREAST-Q questionnaire (quality of life subdivision)
Secondary outcomes (4)
- measure
- Aesthetic result
- timeFrame
- 2 years
- description
- The overall aesthetic result will be measured using 3D-photographs which will be assessed by a panel of independent plastisch surgeons, ex-breast cancer patients and healthy volunteers. In addition, the volume, shape and symmetry will be assessed by the patient using the BREAST-Q questionnaire (satisfaction with breasts subdivisions).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDvan 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
- DERIVEDRijkx 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