Clinical trial NCT02302196: Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
Official title: Autologous Fat Grafting of the Breast in Women With Post Lumpectomy Contour Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Breast
Anomaly of Breast
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kaiser Permanente Northwest members (women) who have undergone lumpectomy and radiation treatment.

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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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

Primary outcomes:
measure: Safety of Autologous Fat Grafting (AFG) compared to standard breast reconstruction for lumpectomy, as measured by the BIRADS scores
timeFrame: 5 years for lumpectomy
Secondary outcomes:
measure: Women undergoing Autologous Fat (AFG) Grafting of the breast
timeFrame: Prior to AFG and 1 year after procedure
Other outcomes:
Locations:
city: Clackamas
country: United States
facility: Kaiser Permanente NW Region, Sunnybrook Medical Office Building
state: Oregon
Study officials:
affiliation: Kaiser Permanente Northwest Region
name: Jennifer Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: