drugset / Trial / NCT02374099

Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant

NCT02374099

Phase 2 Terminated 97 enrolled Celgene Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).

Timeline

Start
2015-03-13
Primary completion
2016-12-13
Completion
2017-11-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 300 mg Oral
Background Fulvestrant Small molecule 500 mg Intramuscular

Indications