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Active, Not Recruiting

NCT Number: NCT02339779

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amstelland Hospital, Amstelveen, Netherlands

Loading trial locations.

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' choice to undergo a breast reconstruction
  • Wanting to participate in this study
  • Patient is able to wear the BRAVA 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
  • Claustrophobia for an MRI-scan

Treatment and study plan

Autologous Fat Transfer

Procedure

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:

  • First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes.
  • 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.
  • 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.

Other names: lipofilling, fat grafting, lipografting, lipoaspirate grafting, autologous fat injection

breast implant

Procedure

Implant-based reconstruction typically will occur as follows:

  • During the primary mastectomy surgery, a tissue expander will be implanted subpectorally.
  • The tissue expander will be gradually filled with sterile saline during outpatient clinic visits.
  • 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.)

Other names: breast prosthesis

Primary outcomes

  1. 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

Secondary outcomes

  1. Aesthetic result

    Time frame: 1 year

    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.

  2. Complications

    Time frame: 1 year

    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 and compared between both grops.

  4. Cost-effectiveness

    Time frame: 1 year

    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).

  5. Sensibility

    Time frame: 1 year

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

  6. Donor site satisfaction

    Time frame: 2 years

    Measurement of quality of life and satisfaction at AFT donor sites, as measured by the BODY-Q questionnaire and additional questions concerning liposuction sites.

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

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

Acronym: BREAST

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2015
Registry last updated
Feb 21, 2022

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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