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NCT02339779: BREAST

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

Active, enrolled NA Last updated 3 February 2022
What this trial tests

NA trial testing autologous fat transfer in Breast Cancer in 196 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 October 2015
Primary endpoint
1 October 2026
1 October 2026

Quick facts

Lead sponsorMaastricht University Medical Center
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment196
Start date1 October 2015
Primary completion1 October 2026
Estimated completion1 October 2026
Sites7 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Maastricht University Medical Center

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Piatkowski AA, Wederfoort JLM, Hommes JE, Schop SSJ, et al · · 2023 · cited 24× · PMID 36857058 · DOI 10.1001/jamasurg.2022.7625
  2. The Crosstalk Between Adipose-Derived Stem or Stromal Cells (ASC) and Cancer Cells and ASC-Mediated Effects on Cancer Formation and Progression-ASCs: Safety Hazard or Harmless Source of Tropism?
    Guillaume VGJ, Ruhl T, Boos AM, Beier JP. · · 2022 · cited 23× · PMID 35274703 · DOI 10.1093/stcltm/szac002
  3. BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.
    Schop SSJ, Hommes JE, Krastev TK, Derks D, et al · · 2021 · cited 14× · PMID 34531218 · DOI 10.1136/bmjopen-2021-051413
  4. Aesthetic Evaluation of Breast Reconstruction with Autologous Fat Transfer vs. Implants.
    Wederfoort JLM, Kleeven A, Hommes JE, Van Kuijk SMJ, et al · · 2023 · cited 6× · PMID 36100783 · DOI 10.1007/s00266-022-03076-2
  5. Superior Sensibility after Full Breast Reconstruction with Autologous Fat Transfer.
    Wederfoort JLM, Schop S, van der Broeck LCA, Hommes JE, et al · · 2024 · cited 4× · PMID 37114918 · DOI 10.1097/prs.0000000000010619
  6. Postmastectomy Breast Reconstruction in Patients with Non-Metastatic Breast Cancer: A Systematic Review.
    Zhong T, Fletcher GG, Brackstone M, Frank SG, et al · · 2025 · cited 2× · PMID 40277787 · DOI 10.3390/curroncol32040231
  7. Postmastectomy Breast Reconstruction in Patients with Non-Metastatic Breast Cancer: An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline.
    Zhong T, Fletcher GG, Brackstone M, Frank SG, et al · · 2025 · cited 1× · PMID 40558300 · DOI 10.3390/curroncol32060357
  8. Bilateral breast infection following total breast reconstruction with autologous fat transfer (AFT): A case report.
    Saelmans AG, Rijkx M, Hommes J, van der Hulst R, et al · · 2023 · cited 1× · PMID 36812827 · DOI 10.1016/j.ijscr.2023.107917

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Maastricht University Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02339779.

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