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Breast CancerBREASTNCT02339779

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

A study testing autologous fat transfer and breast implant in people with Breast Cancer, run by Maastricht University Medical Center at 7 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
autologous fat transfer and breast implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
7 sitesNetherlands
Study dates
Oct 2015to Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Netherlands7 sites

  • Amstelland Hospital

    Amstelveen

  • VU Medical Center

    Amsterdam

  • Alexander Monro Breast cancer hospital

    Bilthoven

  • Amphia Hospital

    Breda

  • Ziekenhuis Groep Twente Hospital

    Hengelo

  • Maastricht University Medical Centre (MUMC+)

    Maastricht, 6229HX

  • Bronovo-MCH Hospital

    The Hague

Other trials in Netherlands

About this study

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

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
Being tested
autologous fat transfer, breast implant
Keywords
fat grafting, fat injection, lipoaspirate, fat transfer, lipofilling, liposculpturing, lipoinjection, lipotransfer, breast reconstruction, external pre-expansion, BRAVA, EVE
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous fat transferProcedure or surgery

    Also called lipofilling, fat grafting, lipografting, lipoaspirate grafting

    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.

  • breast implantProcedure or surgery

    Also called breast prosthesis

    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.)
Study groups in NCT02339779
Study groupRoleWhat they receive
Autologous fat transfer reconstructionExperimentalBreast reconstruction achieved by serial autologous fat transfer (AFT) procedures, accompanied by external tissue expansion of the breast.
Receives: Procedure: autologous fat transfer
Reconstruction with breast implantsActive comparatorControl group will receive implant-based reconstruction, in some cases preceded by the implantation of a tissue expander.
Receives: Procedure: breast implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast-related Quality of life (BREAST_Q)

    Measured by the BREAST-Q questionnaire (quality of life subdivision) preoperatively and 1 year postoperatively

    Measured: 1 year

Secondary outcomes (6)

  1. 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.

    Measured: 1 year

  2. Complications

    Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.

    Measured: 1 year

  3. 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.

    Measured: 5 years

  4. 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).

    Measured: 1 year

  5. Sensibility

    Measurement of skin sensitivity with Semmes Weinstein Monofilaments, 12 months after final reconstruction surgery.

    Measured: 1 year

  6. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02339779
Sponsor's protocol ID
METC142059
Acronym
BREAST
Status last verified
Feb 2022
First submitted
7 Jan 2015
Last updated
21 Feb 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rijkx MEP, van der Venne WBW, Hommes JE, Kuijlaars ZMA, van Kuijk SMJ, Moossdorff M; BREAST trial investigators; Heuts EM, Piatkowski A. Preliminary data on the oncological safety of autologous fat transfer (AFT) for total breast reconstruction from the BREAST trial. J Plast Reconstr Aesthet Surg. 2025 Aug;107:228-237. doi: 10.1016/j.bjps.2025.06.002. Epub 2025 Jun 13.

    PubMed 40652913

  • 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.

    PubMed 39413587

  • 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.

    PubMed 37114918

  • 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.

    PubMed 36857058

  • 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.

    PubMed 34531218

Questions about this trial

What is this clinical trial studying?

A study testing autologous fat transfer and breast implant in people with Breast Cancer, run by Maastricht University Medical Center at 7 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast-related Quality of life (BREAST_Q) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02339779, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.

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