OT3-01-06: A Phase 2 Study Investigating the Safety, Efficacy and Surrogate Biomarkers of Response of 5-Azacitidine (5-AZA) and Entinostat (MS-275) in Patients with Advanced Breast Cancer.
Connolly R, Jankowitz R, Andreopoulou E, Allred J, Jeter S, Zorzi J, Adam B, Espinoza-Delgado I, Baylin S, Zahnow C, Ahuja N, Davidson N, Stearns V. OT3-01-06: A Phase 2 Study Investigating the Safety, Efficacy and Surrogate Biomarkers of Response of 5-Azacitidine (5-AZA) and Entinostat (MS-275) in Patients with Advanced Breast Cancer. Cancer Research 2011, 71: ot3-01-06-ot3-01-06. DOI: 10.1158/0008-5472.sabcs11-ot3-01-06.Peer-Reviewed Original ResearchObjective response rateHistone deacetylase inhibitorsHormone-resistant diseaseAdvanced breast cancerBreast cancerDNA methyltransferase inhibitorHormonal therapyAdvanced human epidermal growth factor receptor 2Response rateMulticenter phase II studyHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Adequate organ functionClinical benefit rateRECIST 1.1 criteriaPhase II studyWeeks of therapyPhase 2 studyProgression-free survivalGrowth factor receptor 2Objective disease responseNegative breast cancerFactor receptor 2Important therapeutic targetCandidate gene methylation