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

Breast Cancer Clinical Trial

— BREAST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02339779
• Other study ID #: METC142059
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2026

Study information

• Verified date: February 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.)

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Complications	Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.	1 year
Secondary	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
Secondary	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
Secondary	Sensibility	Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.	1 year
Secondary	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