We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339779
Recruitment Status : Active, not recruiting
First Posted : January 15, 2015
Last Update Posted : February 21, 2022
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: autologous fat transfer Procedure: breast implant Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

  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.
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:

  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.)

Other Name: breast prosthesis


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Breast-related Quality of life (BREAST_Q) [ Time Frame: 1 year ]
    Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively


Secondary Outcome Measures :
  1. Aesthetic result [ Time Frame: 1 year ]
    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.

  2. Complications [ Time Frame: 1 year ]
    Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.

  3. Oncological safety [ Time Frame: 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 and compared between both grops.

  4. Cost-effectiveness [ Time Frame: 1 year ]
    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).

  5. Sensibility [ Time Frame: 1 year ]
    Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.

  6. Donor site satisfaction [ Time Frame: 2 years ]
    Measurement of quality of life and satisfaction at AFT donor sites, as measured by the BODY-Q questionnaire and additional questions concerning liposuction sites.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339779


Locations
Layout table for location information
Netherlands
Amstelland Hospital
Amstelveen, Netherlands
VU Medical Center
Amsterdam, Netherlands
Alexander Monro Breast cancer hospital
Bilthoven, Netherlands
Amphia Hospital
Breda, Netherlands
Bronovo-MCH Hospital
Hague, Netherlands
Ziekenhuis Groep Twente Hospital
Hengelo, Netherlands
Maastricht University Medical Centre (MUMC+)
Maastricht, Netherlands, 6229HX
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Andrzej Piatkowski de Grzymala, MD, PhD Maastricht University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02339779    
Other Study ID Numbers: METC142059
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht University Medical Center:
fat grafting
fat injection
lipoaspirate
fat transfer
lipofilling
liposculpturing
 lipoinjection
lipotransfer
breast reconstruction
external pre-expansion
BRAVA
EVE