Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

Summary

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.

Timeline

Start

2008-06-13

Primary completion

2011-01-29

Completion

2012-11-26

Outcome

Missed primary endpoint

registry Exemestane 25 mg + Placebo vs Exemestane 25 mg + Entinostat 5 mg; p = 0.06; Hazard Ratio (HR) 0.73 NCT00676663 ↗

Publications

• Yardley DA, Ismail-Khan RR, Melichar B, Lichinitser M, Munster PN, Klein PM, Cruickshank S, Miller KD, Lee MJ, Trepel JB. Randomized phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer progressing on treatment with a nonsteroidal aromatase inhibitor. J Clin Oncol. 2013 Jun 10;31(17):2128-35. doi: 10.1200/JCO.2012.43.7251. Epub 2013 May 6.

Drugs

Indications