NCT04261829

Brief Summary

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Dec 2020Oct 2026

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5.8 years

First QC Date

February 6, 2020

Last Update Submit

July 22, 2021

Conditions

Breast CancerReconstructive SurgeryBreast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Breast-related Quality of life

    Measured by the BREAST-Q questionnaire (quality of life subdivision)

    2 years

Secondary Outcomes (4)

  • Aesthetic result

    2 years

  • Complications

    2 years

  • Oncological safety

    5 years

  • Cost-effectiveness

    2 years

Study Arms (1)

Autologous Fat Transfer

Procedure: Autologous Fat Transfer

Interventions

Autologous Fat TransferPROCEDURE

Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Also known as: Lipofilling
Autologous Fat Transfer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients or women who, due to a gene mutation have a significantly high risk of developing breast cancer, decide to undergo profylactic mastectomy.

You may qualify if:

  • Female gender
  • Age of 18 years and older
  • History or in candidate for a mastectomy procedure in the near future
  • Patients undergoing preventive mastectomy
  • Patients' choice to undergo a breast reconstruction
  • Wanting to participate in this study
  • Patient is able to wear the external expansion device

You may not qualify if:

  • Active smoker or a history of smoking 4 weeks prior to surgery
  • Current substance abuse
  • History of lidocaine allergy
  • History of silicone allergy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Maastricht University Medical Center+

Maastricht, Limburg, 6229 HX, Netherlands

ENROLLING BY INVITATION

Viecuri Venlo

Venlo, Limburg, Netherlands

RECRUITING

Amsterdam University Medical Center (VUMC)

Amsterdam, Netherlands

ENROLLING BY INVITATION

Rijnstate

Arnhem, Netherlands

ENROLLING BY INVITATION

Alexander Monro, Bilthoven

Bilthoven, Netherlands

ENROLLING BY INVITATION

Amphia

Breda, Netherlands

ENROLLING BY INVITATION

Ziekenhuis groep Twente (ZGT)

Hengelo, Netherlands

RECRUITING

Medical Center Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Related Publications (2)

  • van der Venne WBW, Goeree KS, Wederfoort JLM, Hommes JE, van Kuijk SMJ, Heuts EM, Piatkowski de Grzymala AA, Moues CM; BREAST-II trial investigators. Evaluation of the BREAST-II Trial for Total Breast Reconstruction Solely Using Autologous Fat Transfer: 1-Year Follow-Up. Plast Reconstr Surg. 2026 Jan 22. doi: 10.1097/PRS.0000000000012742. Online ahead of print.

    PMID: 41568954DERIVED

  • Rijkx M, Saelmans A, Hommes J, Brandts L, De Bruijn D, Piatkowski A, Heuts E; Breast Reconstruction With External Preexpansion & autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. The Learning Curve of Total Breast Reconstruction With Autologous Fat Transfer. Ann Plast Surg. 2024 Oct 1;93(4):516-526. doi: 10.1097/SAP.0000000000004036. Epub 2024 Jul 15.

    PMID: 39016317DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Andrzej Piatkowski de Grzymala, MD, MSc

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamilla Wederfoort, MD, MSc

CONTACT

0031-(0)43 387 2308sander.schop@mumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

December 9, 2020

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

NL(8)