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Trial Summary

Protocol No.E2112
StatusOPEN TO ACCRUAL
Principal InvestigatorMiller, Kathy
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer
DescriptionThis randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating postmenopausal patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Be 18 years of age or older, male or female
  • Have ER or PR positive adenocarcinoma of the breast, confirmed by histology
  • Have received no more than one prior chemotherapy regimen
  • Must have no known allergies to imidazole drugs (e.g. clotrimazole, ketoconazole, miconazole, econazole, sulconazole, ticonazole, or terconazole), exemestane or entinostat
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast Cancer
Participating InstitutionsIU Health Arnett
  • IU Health Arnett Cancer Care Clinic
IU Health Ball Memorial Hospital
  • IU Health Ball Memorial Hospital
IU Health Central Indiana Cancer Centers
  • CICC East
  • CICC Fishers
Indiana University (IU)
  • Eskenazi Hospital
  • IU Health Methodist Hospital
  • IU Health North (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