Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous fat transfer reconstruction | Experimental | Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast. |
|
| Reconstruction with breast implants | Active Comparator | Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous fat transfer | Procedure | Each procedure consists of the transfer of syringe-aspirated fat (form the abdomen, thighs, flanks) to the breast by injection in the subcutaneous planes. Typically three separate procedures are needed for a complete breast reconstruction:
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast-related Quality of life (BREAST_Q) | Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic result | 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) at 1 year postoperatively. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrzej Piatkowski de Grzymala, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amstelland Hospital | Amstelveen | Netherlands | ||||
| VU Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40652913 | Derived | Rijkx 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. | |
| 39413587 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| breast implant | Procedure | Implant-based reconstruction typically will occur as follows:
(Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.) |
|
|
| Complications | Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events. | 1 year |
| Oncological safety | Oncological follow-up will comply to the guidelines for breast cancer and will take place by a yearly consult with the oncological surgeon (including physical examination and mammography/ultrasound/MRI) for 5 years postoperatively. All (loco)regional and distant recurrences will be recorded and compared between both grops. | 5 years |
| Cost-effectiveness | Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. It will be calculated according to the guidelines of the "Instuction manual cost-effectiveness analysis" (Handleiding kostenonderzoek) of the Dutch Health Institute (Zorginstituut Nederland). | 1 year |
| Sensibility | Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery. | 1 year |
| Donor site satisfaction | Measurement of quality of life and satisfaction at AFT donor sites, as measured by the BODY-Q questionnaire and additional questions concerning liposuction sites. | 2 years |
| Amsterdam |
| Netherlands |
| Alexander Monro Breast cancer hospital | Bilthoven | Netherlands |
| Amphia Hospital | Breda | Netherlands |
| Ziekenhuis Groep Twente Hospital | Hengelo | Netherlands |
| Maastricht University Medical Centre (MUMC+) | Maastricht | 6229HX | Netherlands |
| Bronovo-MCH Hospital | The Hague | Netherlands |
| Derived |
| Wederfoort 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. |
| 37114918 | Derived | Wederfoort 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. |
| 36857058 | Derived | Piatkowski 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. |
| 34531218 | Derived | Schop 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018427 | Breast Implants |
| D019928 | Breast Implantation |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D016462 | Mammaplasty |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
Not provided
Not provided