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.

August 05, 2015
Breast Cancer
Amaryllis Gil, MD

To find out what effects, both good and bad, an experimental drug called entinostat has on cancer, when given together with the standard hormonal drug treatment, exemestane. 

Sponsor: Eastern Cooperative Oncology Group (ECOG)

  • Breast cancer has to be estrogen receptor (ER) and/or progesterone receptor (PR) positive and Her2 negative
  • Patients must have measurable or non-measurable Stage III/locally advanced or metastatic carcinoma of the breast
  • Women and all med are eligible
  • Disease progression any time after non-steroidal AI use in advanced disease setting or Relapse while on or within < 12 months of end of adjuvant non-steroidal AI therapy with or without prior endocrine therapy for advanced disease
  • may have received only one prior chemotherapy regimen for metastatic disease provided treatment was completed > 3 weeks prior to randomization
Accepting Participants
Kathy Seymour, BSN