Status:
COMPLETED
Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
Lead Sponsor:
Kaiser Permanente
Conditions:
Cancer of the Breast
Anomaly of Breast
Eligibility:
FEMALE
18+ years
Brief Summary
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 ...
Detailed Description
About 200 women at Kaiser Permanente Northwest will be in this study. The study will include about 100 women who have had a lumpectomy and consent to be in the research arm and have AFG and 100 from t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02302196
Start Date
September 1 2015
End Date
July 13 2021
Last Update
August 20 2021
Active Locations (1)
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1
Kaiser Permanente NW Region, Sunnybrook Medical Office Building
Clackamas, Oregon, United States, 97015