NCT00828854

Study of the Effect of the Addition of SNDX-275 (Entinostat) to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing

A Phase 2 Multicenter Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The addition of entinostat to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor. It is hypothesized that entinostat with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an acceptable safety profile.

Conditions

• ER+ Breast Cancer

Interventions

Type	Name	Description
DRUG	Entinostat	Entinostat 5 mg PO every week
DRUG	Aromatase Inhibitor (AI) Therapy	AI therapy at labeled dose and schedule as prescribed in clinical practice. AI therapies include: Arimidex® (anastrozole) 1 mg/day by mouth (PO), Fermara® (letrozole) 2.5 mg/day PO , Aromasin® (exemestane) 25 mg/day PO.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-11-24
• Completion: 2009-11-24
• First posted: 2009-01-26
• Last updated: 2022-06-30
• Results posted: 2022-06-30

Locations

6 sites across 2 countries: Ireland, United Kingdom