Clinical trial · Interventional
Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy
the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial
NCT02339779CI-TRIAL-00056633BREASTactive not recruitingN/AClinicalTrials.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)
This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous fat transfer | Procedure | — | UNRESOLVED |
| breast implant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Autologous fat transfer reconstruction
- description
- Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast.
- interventionNames
- Procedure: autologous fat transfer
- type
- ACTIVE_COMPARATOR
- label
- Reconstruction with breast implants
- description
- Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander.
- interventionNames
- Procedure: breast implant
Primary outcomes (1)
- measure
- Breast-related Quality of life (BREAST_Q)
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' choice to undergo a breast reconstruction * Wanting to participate in this study * Patient is able to wear the BRAVA 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 * Claustrophobia for an MRI-scan
References
Publications (5)
- DERIVEDRijkx MEP, van der Venne WBW, Hommes JE, Kuijlaars ZMA, van Kuijk SMJ, Moossdorff M; BREAST trial investigators; Heuts EM, Piatkowski A. Preliminary data on the oncological safety of autologous fat transfer (AFT) for total breast reconstruction from the BREAST trial. J Plast Reconstr Aesthet Surg. 2025 Aug;107:228-237. doi: 10.1016/j.bjps.2025.06.002. Epub 2025 Jun 13. PMID 40652913
- DERIVEDWederfoort JLM, Trommelen DAX, Al Tarah M, Hommes JE, van Kuijk SMJ, van der Hulst RRWJ, Piatkowski AA; BREAST- trial investigators. Volumetric evaluation of autologous fat transfer for total breast reconstruction. J Plast Reconstr Aesthet Surg. 2024 Dec;99:317-328. doi: 10.1016/j.bjps.2024.09.083. Epub 2024 Sep 29. PMID 39413587
- DERIVEDWederfoort JLM, Schop S, van der Broeck LCA, Hommes JE, van Kuijk SMJ, Timmermans F, Smit JM, Heuts EM, de Wit T, van der Hulst RRWJ, Piatkowski AA. Superior Sensibility after Full Breast Reconstruction with Autologous Fat Transfer. Plast Reconstr Surg. 2024 Feb 1;153(2):316-323. doi: 10.1097/PRS.0000000000010619. Epub 2023 Apr 28. PMID 37114918
- DERIVEDPiatkowski AA, Wederfoort JLM, Hommes JE, Schop SSJ, Krastev TK, van Kuijk SMJ, van der Hulst RRWJ; Breast Reconstruction With External Preexpansion & Autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial. JAMA Surg. 2023 May 1;158(5):456-464. doi: 10.1001/jamasurg.2022.7625. PMID 36857058
- DERIVEDSchop SSJ, Hommes JE, Krastev TK, Derks D, Larsen M, Rakhorst H, Schmidbauer U, Smit JM, Tan T, Wehrens K, de Wit T, van der Hulst RRWJ, Piatkowski de Grzymala AA. BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial. BMJ Open. 2021 Sep 16;11(9):e051413. doi: 10.1136/bmjopen-2021-051413. PMID 34531218