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Trial Summary

Protocol No.IUSCC-0556
StatusOPEN TO ACCRUAL
Principal InvestigatorBallinger, Tarah
ScopeLocal
PhasePilot
Age GroupAdult
TitlePilot study of the effect of weight loss on breast tissue and blood biomarkers in women at increased risk for breast cancer
DescriptionThis proposal is investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Eligible women at elevated risk will be consented to undergo imaging (MRI and mammogram) prior to bariatric surgery and approximately 1 year after surgery as well as a fasting blood draw and a breast tissue biopsy prior to bariatric surgery, approximately 2 weeks after surgery, and approximately 1 year after surgery. At 12 months, 50% of excess weight is generally expected. In parallel we will also be assessing 40 normal breast tissue specimens as well as blood samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI, elevated risk control group for our study. The KTB samples will be matched for general risk of breast cancer (>20%), age, race and menopausal status.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patient must be at elevated risk for breast cancer, with more than 20% lifetime risk calculated by any one of the known risk models (Gail, Claus, Tyrer-Cusick or Hughes models) or based on a personal history of lobular carcinoma in situ (LCIS) or atypical hyperplasia.
  • Patients must have a BMI ≥ 30 as calculated by the formula: Weight in pounds / height squared x 703 = BMI
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast Cancer
Participating InstitutionsIU Health North Hospital
  • IU Health North Hospital
Indiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeOther
ContactHeidi S Neuburger, Phone:
Pager: 317-312-3940
Email: hneuburg@iu.edu