AFT: Introduction of a Full Breast Reconstructive Method (BREAST-II)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Reconstruction; Reconstructive Surgery
• Intervention / Treatment: Procedure: Autologous Fat Transfer

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Jamilla Wederfoort, MD, MSc; Phone Number: 0031-(0)43 387 2308; Email: sander.schop@mumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Enrolling by invitation
    • Amsterdam University Medical Center (VUMC)
  • Arnhem, Netherlands
    • Enrolling by invitation
    • Rijnstate
  • Bilthoven, Netherlands
    • Enrolling by invitation
    • Alexander Monro, Bilthoven
  • Breda, Netherlands
    • Enrolling by invitation
    • Amphia
  • Hengelo, Netherlands
    • Recruiting
    • Ziekenhuis Groep Twente (ZGT)
    • Contact: Ute Schmidbauer, MD, MsC
  • Leeuwarden, Netherlands
    • Recruiting
    • Medical Center Leeuwarden
    • Contact: Chantal Mouës, MD, MsC
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Enrolling by invitation
      • Maastricht University Medical Center+
    • Venlo, Limburg, Netherlands
      • Recruiting
      • VieCuri Venlo
      • Contact: An Deliaert, MD, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autologous Fat Transfer	Procedure: Autologous Fat Transfer; 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.; Other Names: Lipofilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast-related Quality of life	Measured by the BREAST-Q questionnaire (quality of life subdivision)	2 years

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Andrzej Piatkowski de Grzymala, MD, MSc, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NL72808.068.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No