E2112: Randomized Phase III Trial of Endocrine Therapy Plus Entinostat or Placebo in Hormone Receptor–Positive Advanced Breast Cancer. A Trial of the ECOG-ACRIN Cancer Research Group

RCT (n=608) found addition of entinostat to exemestane did not improve progression free survival (3.3 vs 3.1 months; HR= 0.87; 95% CI, 0.67 to 1.13) or overall survival (23.4 vs 21.7 months; HR= 0.99; 95% CI, 0.82 to 1.21), vs exemestane alone.

SPS commentary:

Entinostat is a histone deacetylase inhibitors.  Investigation on the use of this agent in breast cancer has now been abdandoned by the manufacturer following the results of this study.

Journal of Clinical Oncology