Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/14/2018 |
| Start Date: | September 2015 |
| End Date: | January 2022 |
| Contact: | Britta Torgrimson-Ojerio, RN, PhD |
| Email: | Britta.N.Torgrimson-Ojerio@kpchr.org |
| Phone: | 503-331-6017 |
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.
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.
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.
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.
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
We found this trial at
1
site
Clackamas, Oregon 97015
Phone: 503-331-6017
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