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Trial Summary

Protocol No.A011401
StatusOPEN TO ACCRUAL
Principal InvestigatorMiller, Kathy
ScopeNational
PhasePhase III
Age GroupAdult
TitleRANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF WEIGHT LOSS IN ADJUVANT TREATMENT OF OVERWEIGHT AND OBESE WOMEN WITH EARLY BREAST CANCER
DescriptionThis randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Females 18 years or older
  • Diagnosed with invasive Breast Cancer
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast Cancer
Participating InstitutionsIndiana University (IU)
  • Eskenazi Hospital
  • IU Health Methodist Hospital
  • IU Health North (For use by Cancer Center CTO only)
  • IU Health West (For use by Cancer Center CTO only)
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu