AFT: Introduction of a Full Breast Reconstructive Method

Breast Cancer Clinical Trial

— BREAST-II  

Official title:

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261829
• Other study ID #: NL72808.068.20
• Status: Recruiting
• Start date: December 9, 2020
• Est. completion date: October 2026

Study information

• Verified date: July 2021
• Source: Maastricht University Medical Center
• Contact: Jamilla Wederfoort, MD, MSc
• Phone: 0031-(0)43 387 2308
• Email: sander.schop[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Reconstruction
• Reconstructive Surgery

Intervention

Procedure:
• Autologous Fat Transfer
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center (VUMC)	Amsterdam
Netherlands	Rijnstate	Arnhem
Netherlands	Alexander Monro, Bilthoven	Bilthoven
Netherlands	Amphia	Breda
Netherlands	Ziekenhuis groep Twente (ZGT)	Hengelo
Netherlands	Medical Center Leeuwarden	Leeuwarden
Netherlands	Maastricht University Medical Center+	Maastricht	Limburg
Netherlands	Viecuri Venlo	Venlo	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast-related Quality of life	Measured by the BREAST-Q questionnaire (quality of life subdivision)	2 years
Secondary	Aesthetic result	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 years
Secondary	Complications	Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.	2 years
Secondary	Oncological safety	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.	5 years
Secondary	Cost-effectiveness	Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.	2 years