NCT00676663

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

A Phase 2, Randomized, Double-Blind, Multicenter Study of Exemestane With and Without SNDX-275 in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer, Progressing on Treatment With a Non-Steroidal Aromatase Inhibitor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Estrogen Receptor-Positive Breast Cancer
• Breast Cancer, Estrogen Receptor-Positive
• ER+ Breast Cancer

Interventions

Type	Name	Description
DRUG	entinostat	Entinostat 5 mg tablet orally once per week
DRUG	exemestane	Exemestane 25 mg tablet orally once daily
DRUG	Placebo	Placebo-matching entinostat tablet orally once per week

Timeline

• Start date: 2008-06-13
• Primary completion: 2011-01-29
• Completion: 2012-11-26
• First posted: 2008-05-13
• Last updated: 2022-05-11
• Results posted: 2019-10-24

Locations

38 sites across 5 countries: United States, Canada, Czechia, Hungary, Russia

Regulatory

• FDA-regulated drug study