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

NCT ID: NCT02302196

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-07-13

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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Conditions

Cancer of the Breast; Anomaly of Breast

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Autologous Fat Grafting of the Breast

Intervention Type: PROCEDURE

In fat grafting, fat tissue is removed from other parts of the body; usually thighs, belly, and buttocks by liposuction. The tissue is then processed and injected into the breast area to reconstruct or recreate the breast. The fat will be removed from by a narrow surgical instrument (cannula) through a small incision. Then the fat will be prepared in a specific way before being replaced back in the body. This preparation may include washing, filtering, and centrifugation (spinning) of the fat. The fat is then placed into the desired area of the breast using either a smaller cannula or needle.

Control arm standard treatment

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.

Control Arm

Intervention Type: OTHER

Retrospective chart review for women who have undergone standard breast reconstruction for lumpectomy.

Interventions

Autologous Fat Grafting of the Breast

In fat grafting, fat tissue is removed from other parts of the body; usually thighs, belly, and buttocks by liposuction. The tissue is then processed and injected into the breast area to reconstruct or recreate the breast. The fat will be removed from by a narrow surgical instrument (cannula) through a small incision. Then the fat will be prepared in a specific way before being replaced back in the body. This preparation may include washing, filtering, and centrifugation (spinning) of the fat. The fat is then placed into the desired area of the breast using either a smaller cannula or needle.

Intervention Type: PROCEDURE

Control Arm

Retrospective chart review for women who have undergone standard breast reconstruction for lumpectomy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northwest Region

Locations

Kaiser Permanente NW Region, Sunnybrook Medical Office Building

Clackamas, Oregon, United States

Countries

United States

Other Identifiers

KPNW Fat Grafting 001

Identifier Type: -

Identifier Source: org_study_id