CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Entinostat +2 moredrug
Likely dose
Not stated in 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/NCT02708680
NCT02708680Phase 2Completed

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study of Atezolizumab With or Without Entinostat in Patients With Advanced Triple Negative Breast Cancer, With a Phase 1b Lead in Phase

Syndax Pharmaceuticals·interventional·Posted Mar 15, 2016·Updated Dec 4, 2024

In Brief

A Phase 2 clinical trial evaluating Entinostat, Atezolizumab, and 1 other intervention for Breast Cancer. Completed, enrolled 89 participants across 29 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in participants with Advanced Triple Negative Breast Cancer (aTNBC). Additionally, the purpose of the study is to assess how effective entinostat and atezolizumab are in combination in participants with aTNBC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesGeorgia, United States
CollaboratorsRoche Pharma AG

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 15, 2016
Enrollment StartMay 1, 2016
Primary CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.3 years ago

Interventions

Entinostatdrug

An orally available histone deacetylases inhibitor (HDAC).

Atezolizumabdrug

A humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death ligand 1 (PD-L1).

Placebodrug

A pill containing no active drug ingredient