A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer

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.

E2112
Breast Cancer
Amaryllis Gil, MD

This 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.

View more information about E2112 at ClinicalTrials.gov

  • Patients must not have known central nervous system metastasis or a history of central nervous system (CNS) metastases
  • Patients must have no known allergies to imidazole drugs
  • Patients must be able to swallow tablets
  • Estrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast
  • Pre/Perimenopausal women and all men are eligible for this trial
  • Patients may have received one prior chemotherapy regimen for metastatic disease
  • Patients must be able to swallow tablets
Accepting Participants
III
Kathy Seymour, BSN
(331) 221-2168