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NCT Number: NCT04261829

AFT: Introduction of a Full Breast Reconstructive Method

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Neoplasms Neoplasms by Site Reconstructive Surgery Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maastricht University Medical Center+, Maastricht, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Autologous Fat Transfer

Procedure

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.

Other names: Lipofilling

Primary outcomes

  1. Breast-related Quality of life

    Time frame: 2 years

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

Secondary outcomes

  1. Aesthetic result

    Time frame: 2 years

    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).

  2. Complications

    Time frame: 2 years

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

  3. 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.

  4. Cost-effectiveness

    Time frame: 2 years

    Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamilla Wederfoort, MD, MSc

CONTACT

[email protected]

0031-(0)43 387 2308

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

Acronym: BREAST-II

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2020
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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