Last reviewed · How we verify
NCT02339779: BREAST
the Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy Trial
NA trial testing autologous fat transfer in Breast Cancer in 196 participants. Participants enrolled and being followed up; not accepting new ones.
1 October 2026
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 196 |
| Start date | 1 October 2015 |
| Primary completion | 1 October 2026 |
| Estimated completion | 1 October 2026 |
| Sites | 7 locations across Netherlands |
Drugs / interventions tested
- autologous fat transfer
- breast implant
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
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.
-
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
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02339779
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Maastricht University Medical Center trials
Trials by the same sponsor.
- NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
- NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
- NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
- NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
- NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02339779 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 3 February 2022
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing