Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects

Completed

• Conditions: Cancer of the Breast; Anomaly of Breast
• Interventions: Procedure: Autologous Fat Grafting of the Breast; Other: Control Arm

• Registration Number: NCT02302196
• Lead Sponsor: Kaiser Permanente

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 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.

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 the control arm (retrospective chart review).

Autologous Fat Grafting Arm: Breast-Q survey of patient satisfaction will be collected before and after AFG. Assessments will be done 3 months post grafting for efficacy (excellent 100% correction of defect), good (75% correction of defect), fair (50% correction of defect), poor 25% or less correction of defect) result will be recorded. 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. A mammographic assessment of the breast, scored by radiologist in a 6 step scoring system (BIRADS score) will be done 1 year after AFG. BIRADS scores and new physical finding will continue to be collected for a 5 year period post AFG post lumpectomy group.

Control (non-Autologous Fat Grafting) arm: Retrospective chart review for women who have undergone standard treatment to treatment to reconstruct their breasts. Data collected will include; 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.

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Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-26
• Study Start: 2015-09
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autologous Fat Grafting of the breast	Autologous Fat Grafting of the Breast	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.
Control arm standard treatment	Control Arm	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.

Primary Outcome Measures

Name	Time	Method
Safety of Autologous Fat Grafting (AFG) compared to standard breast reconstruction for lumpectomy, as measured by the BIRADS scores	5 years for lumpectomy	The experimental AFG group will have the same or less change in the BIRADS scores than the control non-AFG group.

Secondary Outcome Measures

Name	Time	Method
Women undergoing Autologous Fat (AFG) Grafting of the breast	Prior to AFG and 1 year after procedure	The Breast Q survey will be administered to women before and after the AFG procedure

Trial Locations

Locations (1)

Kaiser Permanente NW Region, Sunnybrook Medical Office Building; 🇺🇸 Clackamas, Oregon, United States