Breast Cancer ECOG E2112

April 11, 2017

Sponsor: National Cancer Institute (NCI)

Number: ECOG E2112
Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III trials are new treatments that have worked well in a small number of patients with a this disease) studies Exemestane and Entinostat to see how well they work compared to Exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. High amounts of estrogen (primary female hormone) can cause the growth of breast cancer cells. Endocrine/Hormone therapy using Exemestane may fight breast cancer by lowering the amount of estrogen the body makes or interferes with the effects. 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.

Who’s eligible: 

  • Estrogen receptor (ER) and/or progesterone receptor (PR) (receptors that may be found in breast cancer cells) positive histologically confirmed adenocarcinoma of the breast with staining of >= 1% cells will be considered positive. Receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic).
  • Patients must have measurable or non-measurable stage III/locally advanced or metastatic (breast cancer that has spread beyond the breast to the chest wall or the skin of the breast, or to many lymph nodes in the underarm area, or to other organs) carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =< 4 weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved.
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut.

Cancer Clinical Research Office