Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients (AFT-R)

June 9, 2026 updated by: Maastricht University Medical Center

Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients

The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are:

Does AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients?

Researchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients.

Participants will:

Undergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female, aged >18 years.
  • BMI between > 22 and <35 kg/m2
  • History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).
  • May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation.
  • Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.
  • Medically fit for surgery (ASA I-III).
  • Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).
  • No evidence of active cancer at enrollment; remission confirmed.
  • Able to wear the EVE device (if randomized in AFT).
  • Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.

Exclusion Criteria:

  • Prior autologous breast reconstruction on the intended side. BMI <22 or >35 kg/m2
  • Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).
  • Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).
  • Current chemotherapy or completed less than 4 weeks prior to enrollment.
  • Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).
  • Active smoker or not abstinent for at least 6 weeks pre-operatively.
  • Pregnant at time of enrollment.
  • In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).
  • Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).
  • Allergy to lidocaine or silicone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: DIEP reconstruction
Procedure: Deep inferior epigastric perforator flap
Deep inferior epigastric perforator flap as breast reconstruction
Experimental: AFT
Procedure: Autologous fat transfer
Autologous fat transfer as total breast reconstruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
to determine whether autologous fat transfer (AFT) is non-inferior to DIEP flap breast re-construction regarding breast satisfaction, as measured by the BREAST-Q, 12 months after the final reconstructive procedure in irradiated breast cancer patients;
Time Frame: 12 months
One of the primary outcomes is the BREAST-Q "Satisfaction with Breasts" score at 12 months post-reconstruction. This validated, patient-reported measure (0-100 scale) as-sesses satisfaction with breast appearance and feel.
12 months
to assess whether AFT is superior to DIEP flap reconstruction in terms of the incidence of major complications requiring reoperation or hospital readmission.
Time Frame: 12 months
The second primary outcome measure is the incidence of major complications (i.e. complications requiring reoperation or hospital readmission such as hematoma, venous/arterial insufficiency, partial/total flap loss, and infection/abscess).
12 months
cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated.
Time Frame: 12 months
The third primary outcome is cost-effective-ness. We will collect detailed healthcare and societal costs per patient using hospital records, CRFs, and a study-adapted patient-reported iMCQ and iPCQ (for health care resource use and productivity loss). QALYs will be calculated from EQ-5D-5L data at multiple timepoints. We will compare cost per QALY (ICER) between AFT and DIEP, and conduct a budget impact analysis.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Well-being: Abdomen (BREAST-Q)
Time Frame: 12 months
Physical Well-being: Abdomen (donor site), assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the abdominal donor site.
12 months
Complications (Minor & General)
Time Frame: 12 months
Incidence of minor recipient-site and donor-site com-plications (i.e. complications taking care of at the outpatient clinic) managed conserva-tively (e.g. wound problems/dehiscence, infection, seroma, hematoma, and abdominal bulging), and any general (systemic) complications related to surgery or hospitalization (e.g. pulmonary embolism, pneumonia).
12 months
Oncologic Safety
Time Frame: 12 months
Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT's oncologic safety.
12 months
Sensory Recovery
Time Frame: 12 months
Evaluate return of breast skin sensation at 12 months with mono-filament testing to compare sensory outcomes between techniques [in MUMC+ only].
12 months
Physical Function and Pain
Time Frame: 12 months
We will assess post-mastectomy pain and phantom sensations using relevant BREAST-Q items or a brief questionnaire. For donor site function, DIEP patients may be asked about core strength (e.g. sit-ups), while AFT patients will be monitored for minor issues like contour irreg-ularities. Assessments will be based on patient reports and clinical exam.
12 months
Breast Aesthetics & Volume
Time Frame: 12 months
Breast volume and shape assessed 12 months after reconstruction using 3D Vectra photography and the BREAST-V volume calculator (https://braflap.com/breast-v/, Sternal Notch - Nipple distance [cm], Fold Projection - Inframammary Fold distance [cm], and Nipple - Inframammary Fold distance [cm]) . Fat graft retention in the AFT group will be estimated by total grafted volume versus final breast volume. Standardized photographs (2D and 3D) will document cosmetic out-comes which can be assessed by a an expert panel.
12 months
Radiation-Associated Changes
Time Frame: 12 months
We will grade radiation fibrosis/telangiectasia in the chest skin at baseline (just before recon) and at 12 months, using the Common Terminology Criteria for Adverse Events (CTCAE) score (for radiation dermatitis/fibrosis). If AFT improves the pliability or vascularity of skin, we might see an improvement in grade (e.g. from CTCAE 2 to 1). If DIEP flap breast reconstruction brings fresh skin, the radiated skin might be partially replaced or supplemented. This is some-what subjective, but we will attempt consistent grading. Also, if any ulcers or non-healing radi-ation damage was present, we will see if healed after reconstruction
12 months
Physical Well-being: Chest (BREAST-Q)
Time Frame: 12 months
Physical Well-being: Chest, assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better physical well-being of the chest.
12 months
Sexual Well-being (BREAST-Q)
Time Frame: 12 months
Sexual Well-being, assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better sexual well-being.
12 months
Breast Sensation (BREAST-Q)
Time Frame: 12 months
Breast Sensation, assessed using the BREAST-Q Sensation Module. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better breast sensation.
12 months
Donor Site Satisfaction (BODY-Q)
Time Frame: 12 months
Satisfaction with donor site appearance, assessed using the BODY-Q. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating greater satisfaction with the donor site.
12 months
Adverse Effects of Radiation (BREAST-Q)
Time Frame: 12 months
Adverse Effects of Radiation, assessed using the BREAST-Q Reconstruction Module. Scores are transformed to a scale ranging from 0 to 100. Specify according to the scoring manual whether higher scores indicate fewer or more adverse effects of radiation.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academisch Ziekenhuis Maastricht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL-010887
  • 2025008144 (Other Grant/Funding Number: Zorginstituut Nederland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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