Clinical trial · Observational
Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
NCT02302196CI-TRIAL-00053420completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the safety and efficacy of breast reconstruction using Autologous Fat Grafting (AFG) for women post lumpectomy that have contour defects. The study hypothesis is that AFG has emerged as a less invasive alternative to breast reconstruction post mastectomy. AFG could be used to treat breast contour defects with much less invasive outpatient surgery, using the patient's own cells and tissues, which overall reduces risk.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anomaly of Breast | — | UNRESOLVED | — |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Fat Grafting of the Breast | Procedure | — | UNRESOLVED |
| Control Arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Autologous Fat Grafting of the breast
- description
- Approximately 100 women who have had a lumpectomy and qualify, will be offered Autologous Fat Grafting (AFG) procedure. Patients will be assessed 3 months post grafting for safety and efficacy by Breast-Q survey, mammography BIRADS scoring and physical assessment. The AFG may be repeated x 2 at a 3-6 month interval if deemed necessary by the treating surgeon, then reassessed again 3 months later in the same way. Repeat mammogram will be done 1 year post AFG.
- interventionNames
- Procedure: Autologous Fat Grafting of the Breast
- label
- Control arm standard treatment
- description
- Retrospective chart review will be done in 100 women who have undergone standard treatment for breast contour defect after lumpectomy.The control group will be measured by compiling BIRADS scores as well as frequency of subsequent surgical intervention (as necessitated by increased BIRADS scores or by new physical findings on exam) over a 5 year period post lumpectomy.
- interventionNames
- Other: Control Arm
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women * Age 18 \> y/o * If patient has had lumpectomy and radiation, need to be at least 3 years out from completion of radiation * Must be a Kaiser Permanente Northwest Member Exclusion Criteria: * Active smokers, cannot quit smoking for at least one month before and after procedures * Patients who have such extensive skin scarring that elasticity is lost * Patients who have little to no subcutaneous donor fat * Patients with BIRAD's 3 or greater mammograms after treatment * Patients with aggressive cancer for which cure is the goal (do not want to exclude patients that want palliative procedure) - inflammatory breast cancer * Patients with triple negative cancer - ER -, PR -, Her2-neu - * Patients with BRCA or CHEK-2 gene mutations or those with strong family history of breast cancer \[more than 2 first degree relatives with breast cancer\] * Patients that have had a lumpectomy for breast cancer who have declined radiation therapy when it was recommended to reduce risk of local recurrence (should not exclude patients over 70 y/o who have elected to have lumpectomy and anti-estrogen therapy instead of lumpectomy and radiation) * Oncoplastic reduction patients * Comorbidities that preclude multiple procedures being done * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.