AFT: Introduction of a Full Breast Reconstructive Method

Recruiting

• Conditions: Breast Cancer; Reconstructive Surgery; Breast Reconstruction
• Interventions: Procedure: Autologous Fat Transfer

• Registration Number: NCT04261829
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Study Start: 2020-12-09
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-29
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autologous Fat Transfer	Autologous Fat Transfer	-

Primary Outcome Measures

Name	Time	Method
Breast-related Quality of life	2 years	Measured by the BREAST-Q questionnaire (quality of life subdivision)

Secondary Outcome Measures

Name	Time	Method
Oncological safety	5 years	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.
Cost-effectiveness	2 years	Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.
Aesthetic result	2 years	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).
Complications	2 years	Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.

Trial Locations

Locations (8)

Amsterdam University Medical Center (VUMC); 🇳🇱 Amsterdam, Netherlands

Maastricht University Medical Center+; 🇳🇱 Maastricht, Limburg, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Alexander Monro, Bilthoven; 🇳🇱 Bilthoven, Netherlands

Viecuri Venlo; 🇳🇱 Venlo, Limburg, Netherlands

Amphia; 🇳🇱 Breda, Netherlands

Ziekenhuis groep Twente (ZGT); 🇳🇱 Hengelo, Netherlands

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands