Breast Cancer Clinical Trial
— BREAST-IIOfficial title:
Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | October 2026 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam University Medical Center (VUMC) | Amsterdam | |
Netherlands | Rijnstate | Arnhem | |
Netherlands | Alexander Monro, Bilthoven | Bilthoven | |
Netherlands | Amphia | Breda | |
Netherlands | Ziekenhuis groep Twente (ZGT) | Hengelo | |
Netherlands | Medical Center Leeuwarden | Leeuwarden | |
Netherlands | Maastricht University Medical Center+ | Maastricht | Limburg |
Netherlands | Viecuri Venlo | Venlo | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast-related Quality of life | Measured by the BREAST-Q questionnaire (quality of life subdivision) | 2 years | |
Secondary | 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 | |
Secondary | Complications | Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events. | 2 years | |
Secondary | 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 | |
Secondary | Cost-effectiveness | Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment. | 2 years |
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