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

Cancer of the Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302196
• Other study ID #: KPNW Fat Grafting 001
• Status: Completed
• Start date: September 2015
• Est. completion date: July 13, 2021

Study information

• Verified date: August 2021
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anomaly of Breast
• Breast Neoplasms
• Cancer of the Breast

Intervention

Procedure:
• 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.

Other:
• Control Arm
Retrospective chart review for women who have undergone standard breast reconstruction for lumpectomy.

Locations

Country	Name	City	State
United States	Kaiser Permanente NW Region, Sunnybrook Medical Office Building	Clackamas	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Autologous Fat Grafting (AFG) compared to standard breast reconstruction for lumpectomy, as measured by the BIRADS scores	The experimental AFG group will have the same or less change in the BIRADS scores than the control non-AFG group.	5 years for lumpectomy
Secondary	Women undergoing Autologous Fat (AFG) Grafting of the breast	The Breast Q survey will be administered to women before and after the AFG procedure	Prior to AFG and 1 year after procedure