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Not yet recruiting NCT07641985

Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients

No phase Interventional Breast Cancer Breast Reconstruction Breast Reconstruction After Mastectomy Breast Cancer Radiation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous fat transfer, Deep inferior epigastric perforator flap.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Reconstruction, Breast Reconstruction After Mastectomy, Breast Cancer Radiation. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients

Overview

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

Interventions

  • Procedure Autologous fat transfer
    Autologous fat transfer as total breast reconstruction
  • Procedure Deep inferior epigastric perforator flap
    Deep inferior epigastric perforator flap as breast reconstruction

Primary outcome measures

  • 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]
  • 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]
  • cost-effectiveness of AFT compared with DIEP flap reconstruction will be evaluated. [Time frame: 12 months]
Secondary outcome measures (12)
  • Physical Well-being: Abdomen (BREAST-Q) [Time frame: 12 months]
  • Complications (Minor & General) [Time frame: 12 months]
  • Oncologic Safety [Time frame: 12 months]
  • Sensory Recovery [Time frame: 12 months]
  • Physical Function and Pain [Time frame: 12 months]
  • Breast Aesthetics & Volume [Time frame: 12 months]
  • Radiation-Associated Changes [Time frame: 12 months]
  • Physical Well-being: Chest (BREAST-Q) [Time frame: 12 months]
  • Sexual Well-being (BREAST-Q) [Time frame: 12 months]
  • Breast Sensation (BREAST-Q) [Time frame: 12 months]
  • Donor Site Satisfaction (BODY-Q) [Time frame: 12 months]
  • Adverse Effects of Radiation (BREAST-Q) [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • AzM — Maastricht

Identifiers

NCT: NCT07641985 · NL-010887 · 2025008144

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗