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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Fat Transfer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Fat Transfer | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Breast-related Quality of life | Measured by the BREAST-Q questionnaire (quality of life subdivision) | 2 years |
| 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). | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients or women who, due to a gene mutation have a significantly high risk of developing breast cancer, decide to undergo profylactic mastectomy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamilla Wederfoort, MD, MSc | Contact | 0031-(0)43 387 2308 | sander.schop@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Andrzej Piatkowski de Grzymala, MD, MSc | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center+ | Enrolling by invitation | Maastricht | Limburg | 6229 HX | Netherlands | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41568954 | Derived | 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. | |
| 39016317 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Complications | Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events. | 2 years |
| 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. | 5 years |
| Cost-effectiveness | Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. | 2 years |
| Viecuri Venlo |
| Recruiting |
| Venlo |
| Limburg |
| Netherlands |
|
| Amsterdam University Medical Center (VUMC) | Enrolling by invitation | Amsterdam | Netherlands |
| Rijnstate | Enrolling by invitation | Arnhem | Netherlands |
| Alexander Monro, Bilthoven | Enrolling by invitation | Bilthoven | Netherlands |
| Amphia | Enrolling by invitation | Breda | Netherlands |
| Ziekenhuis groep Twente (ZGT) | Recruiting | Hengelo | Netherlands |
|
| Medical Center Leeuwarden | Recruiting | Leeuwarden | Netherlands |
|
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |