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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02339779

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

196

Enrollment

Locations

Arms

132

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Breast-related Quality of life (BREAST_Q) [1 year]
Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively

Secondary Outcome Measures

Aesthetic result [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.
Complications [1 year]
Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.
Oncological safety [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.
Cost-effectiveness [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).
Sensibility [1 year]
Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.
Donor site satisfaction [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Amstelland Hospital	Amstelveen	Netherlands
2	VU Medical Center	Amsterdam	Netherlands
3	Alexander Monro Breast cancer hospital	Bilthoven	Netherlands
4	Amphia Hospital	Breda	Netherlands
5	Bronovo-MCH Hospital	Hague	Netherlands
6	Ziekenhuis Groep Twente Hospital	Hengelo	Netherlands
7	Maastricht University Medical Centre (MUMC+)	Maastricht	Netherlands	6229HX