CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Azacitidine +3 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/NCT01349959
NCT01349959Phase 2Completed
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Phase II Study of Azacitidine and Entinostat (SNDX-275) in Patients With Advanced Breast Cancer

National Cancer Institute (NCI)·interventional·Posted May 9, 2011·Updated Apr 27, 2025

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Entinostat, and 2 other interventions for Male Breast Carcinoma and 4 related conditions. Completed, enrolled 58 participants across 7 sites.

Detailed Summary

This phase II trial studies how well giving azacitidine and entinostat work in treating patients with advanced breast cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2011
Enrollment StartAug 15, 2011
Primary CompletionMar 27, 2014
Study CompletionNov 7, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.1 years ago

Interventions

Azacitidinedrug

Given SC

Entinostatdrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies