Trial reportSignal transduction and targeted therapy2026
Entinostat plus exemestane for hormone receptor-positive advanced breast cancer: long-term overall survival results from the EOC103A3101 randomized controlled trial.
Trial report in Signal transduction and targeted therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03538171 (A Randomized Phase III Clinical Study of Entinostat/Placebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer), which is not on this map. Not yet cited in PubMed.
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A Randomized Phase III Clinical Study of Entinostat/Placebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer
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18 authors.
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Abstract
The addition of entinostat, a histone deacetylase inhibitor, to exemestane has demonstrated improved progression-free survival (PFS) in hormone receptor-positive (HR + ), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) following endocrine therapy failure in the EOC103A3101 randomized trial (NCT03538171). This study reports long-term overall survival (OS) results. In this study, 354 patients with HR + /HER2- ABC that had recurred or progressed after endocrine therapy were randomized (2:1) to receive entinostat plus exemestane (n = 235) or placebo plus exemestane (n = 119). After a median follow-up of 31.8 months, the median OS was 38.6 months (95% confidence interval [CI]: 29.6-44.0) in the entinostat-exemestane group versus 29.2 months (95% CI: 22.5-41.6) in the placebo-exemestane group (hazard ratio [HR] 0.83, 95% CI: 0.62-1.10, P = 0.184). The entinostat-exemestane group demonstrated more pronounced OS benefits when adjusting subsequent antitumor therapies such as cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, or the combination of endocrine therapy, CDK4/6 inhibitors, and chemotherapy. The sensitivity analysis based on the per-protocol set showed more significant OS benefits. The median time to post-discontinuation chemotherapy and chemotherapy-free survival in the entinostat-exemestane group were 11.7 and 9.3 months, respectively, compared to 6.8 and 5.6 months in the placebo-exemestane group (both P < 0.05). Grade ≥3 treatment-emergent adverse events occurred in 65.5% of patients in the entinostat-exemestane group, without new safety signals observed. In conclusion, among patients with HR + /HER2- ABC after endocrine therapy failure, entinostat plus exemestane was associated with a numerically longer OS, with an acceptable safety profile.
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