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

NCT02339779 | Active Not Recruiting

• 1 other identifier: METC142059
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Breast Cancer

Keywords

fat grafting; fat injection; lipoaspirate; fat transfer; lipofilling; liposculpturing; lipoinjection; lipotransfer; breast reconstruction; external pre-expansion; BRAVA; EVE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Aesthetic result

  1 year

• Complications

  1 year

• Oncological safety

  5 years

• Cost-effectiveness

  1 year

• Sensibility

  1 year

Study Arms (2)

Autologous fat transfer reconstruction

EXPERIMENTAL

Breast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast.

Procedure: autologous fat transfer

Reconstruction with breast implants

ACTIVE COMPARATOR

Control group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander.

Procedure: breast implant

Interventions

autologous fat transfer PROCEDURE

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: 1. First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes. 2. 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. 3. 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.

Also known as: lipofilling, fat grafting, lipografting, lipoaspirate grafting, autologous fat injection

Autologous fat transfer reconstruction

breast implant PROCEDURE

Implant-based reconstruction typically will occur as follows: 1. During the primary mastectomy surgery, a tissue expander will be implanted subpectorally. 2. The tissue expander will be gradually filled with sterile saline during outpatient clinic visits. 3. 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.)

Also known as: breast prosthesis

Reconstruction with breast implants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active smoker or a history of smoking 4 weeks prior to surgery
• Current substance abuse
• History of lidocaine allergy
• History of silicone allergy
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

Amstelland Hospital

Amstelveen, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Alexander Monro Breast cancer hospital

Bilthoven, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Ziekenhuis Groep Twente Hospital

Hengelo, Netherlands

Location

Maastricht University Medical Centre (MUMC+)

Maastricht, 6229HX, Netherlands

Location

Bronovo-MCH Hospital

The Hague, Netherlands

Location

Related Publications (4)

• Wederfoort JLM, Trommelen DAX, Al Tarah M, Hommes JE, van Kuijk SMJ, van der Hulst RRWJ, Piatkowski AA; BREAST- trial investigators. Volumetric evaluation of autologous fat transfer for total breast reconstruction. J Plast Reconstr Aesthet Surg. 2024 Dec;99:317-328. doi: 10.1016/j.bjps.2024.09.083. Epub 2024 Sep 29.

  PMID: 39413587 DERIVED

• Wederfoort JLM, Schop S, van der Broeck LCA, Hommes JE, van Kuijk SMJ, Timmermans F, Smit JM, Heuts EM, de Wit T, van der Hulst RRWJ, Piatkowski AA. Superior Sensibility after Full Breast Reconstruction with Autologous Fat Transfer. Plast Reconstr Surg. 2024 Feb 1;153(2):316-323. doi: 10.1097/PRS.0000000000010619. Epub 2023 Apr 28.

  PMID: 37114918 DERIVED

• Piatkowski AA, Wederfoort JLM, Hommes JE, Schop SSJ, Krastev TK, van Kuijk SMJ, van der Hulst RRWJ; Breast Reconstruction With External Preexpansion & Autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial. JAMA Surg. 2023 May 1;158(5):456-464. doi: 10.1001/jamasurg.2022.7625.

  PMID: 36857058 DERIVED

• 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.

  PMID: 34531218 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Breast Implants; Breast Implantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Mammaplasty; Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Andrzej Piatkowski de Grzymala, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 15, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)