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

NCT07641985 | Not Yet Recruiting

• 2 other identifiers: NL-0108872025008144
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Breast Reconstruction; Breast Reconstruction After Mastectomy; Breast Cancer Radiation; Lipofilling

Keywords

Lipofilling; Breast reconstruction; Irradiated patients

Outcome Measures

Primary Outcomes (3)

• 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;

  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.

  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.

  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 Outcomes (12)

• Physical Well-being: Abdomen (BREAST-Q)

  12 months

• Complications (Minor & General)

  12 months

• Oncologic Safety

  12 months

• Sensory Recovery

  12 months

• Physical Function and Pain

  12 months

Study Arms (2)

DIEP reconstruction

ACTIVE COMPARATOR

Procedure: Deep inferior epigastric perforator flap

AFT

EXPERIMENTAL

Procedure: Autologous fat transfer

Interventions

Autologous fat transfer PROCEDURE

Autologous fat transfer as total breast reconstruction

AFT

Deep inferior epigastric perforator flap PROCEDURE

Deep inferior epigastric perforator flap as breast reconstruction

DIEP reconstruction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: the study enrolls only biological females and will accept only cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Academisch Ziekenhuis Maastricht: collaborator

Study Sites (1)

AzM

Maastricht, Limburg, 6229, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)