CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Entinostat +1 moredrug
Likely dose
Entinostat 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00828854
NCT00828854Phase 2Completed
CompareCT.gov

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

Syndax Pharmaceuticals·interventional·Posted Jan 26, 2009·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating Entinostat and Aromatase Inhibitor (AI) Therapy for ER+ Breast Cancer. Completed, enrolled 27 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsER+ Breast Cancer
CountriesIreland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2009
Enrollment StartOct 1, 2008
Primary CompletionNov 24, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.4 years ago

Interventions

Entinostatdrug

Entinostat 5 mg PO every week

Aromatase Inhibitor (AI) Therapydrug

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.