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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: autologous fat transfer Procedure: breast implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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:
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:
(Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.)
Other Name: breast prosthesis
- 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
- 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.
- Complications [ Time Frame: 1 year ]Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.
- 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.
- 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).
- Sensibility [ Time Frame: 1 year ]Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.
- 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.
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
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
|VU Medical Center|
|Alexander Monro Breast cancer hospital|
|Ziekenhuis Groep Twente Hospital|
|Maastricht University Medical Centre (MUMC+)|
|Maastricht, Netherlands, 6229HX|
|Principal Investigator:||Andrzej Piatkowski de Grzymala, MD, PhD||Maastricht University Medical Center|
|Responsible Party:||Maastricht University Medical Center|
|Other Study ID Numbers:||
|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|