Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy (BREAST)

the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: autologous fat transfer; Procedure: breast implant

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amstelveen, Netherlands
    • Amstelland Hospital
  • Amsterdam, Netherlands
    • VU Medical Center
  • Bilthoven, Netherlands
    • Alexander Monro Breast cancer hospital
  • Breda, Netherlands
    • Amphia Hospital
  • Hague, Netherlands
    • Bronovo-MCH Hospital
  • Hengelo, Netherlands
    • Ziekenhuis Groep Twente Hospital
  • Maastricht, Netherlands, 6229HX
    • Maastricht University Medical Centre (MUMC+)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female gender
• Age of 18 years and older
• History or in candidate for a mastectomy procedure in the near future
• Patients' choice to undergo a breast reconstruction
• Wanting to participate in this study
• Patient is able to wear the BRAVA 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
• Claustrophobia for an MRI-scan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous fat transfer reconstruction; Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast.	Procedure: autologous fat transfer; 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: First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes.; Second session is preceeded by wearing an external pre-expansion device to prepare the recipient site for grafting. It aims to give the breast its shape and initial volume.; Third session is also preceded by external pre-expansion and aims to provide extra volume of the breast to achieve symmetry with the healthy breast.; Other Names: lipofilling; fat grafting; lipografting; lipoaspirate grafting; autologous fat injection
Active Comparator: Reconstruction with breast implants; Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander.	Procedure: breast implant; Implant-based reconstruction typically will occur as follows: During the primary mastectomy surgery, a tissue expander will be implanted subpectorally.; The tissue expander will be gradually filled with sterile saline during outpatient clinic visits.; When the desired volume is achieved, a second operation will be planned, to exchange the tissue expanded with the definite breast implant. (Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.); Other Names: breast prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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) at 1 year postoperatively.	1 year
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

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, PhD, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 15, 2015

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: breast reconstruction; fat grafting; fat injection; lipoaspirate; fat transfer; lipofilling; liposculpturing; lipoinjection; lipotransfer; external pre-expansion; BRAVA; EVE
• Other Study ID Numbers: METC142059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No