Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial

Siegel, 2022, Cancer statistics, CA Cancer J Clin, 2022, 72 Bertos, 2011, Breast cancer—one term, many entities?, J Clin Invest, 121, 3789, 10.1172/JCI57100 Andrahennadi, 2021, Current landscape of targeted therapy in hormone receptor-positive and HER2-negative breast cancer, Curr Oncol, 28, 1803, 10.3390/curroncol28030168 Senkus, 2015, Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up, Ann Oncol, 26, v8, 10.1093/annonc/mdv298 Cardoso, 2017, ESO-ESMO international consensus guidelines for advanced breast cancer (abc 3), Ann Oncol, 28, 16, 10.1093/annonc/mdw544 National Comprehensive Cancer network, NCCN clinical practice guidelines in oncology. Breast Cancer. Version 2.2022. Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Published on December 20, 2021. Lei, 2019, Endocrine therapy resistance: new insights, Breast, 48, S26, 10.1016/S0960-9776(19)31118-X Rani, 2019, Endocrine resistance in hormone receptor positive breast cancer-from mechanism to therapy, Front Endocrinol, 10, 245, 10.3389/fendo.2019.00245 Osborne, 2011, Mechanisms of endocrine resistance in breast cancer, Annu Rev Med, 62, 233, 10.1146/annurev-med-070909-182917 Saxena, 2010, Epigenetic reactivation of estrogen receptor: promising tools for restoring response to endocrine therapy, Mol Cell Pharmacol, 2, 191 Delcuve, 2012, Roles of histone deacetylases in epigenetic regulation: emerging paradigms from studies with inhibitors, Clin Epigenet, 4, 5, 10.1186/1868-7083-4-5 Brabletz, 2012, To differentiate or not–routes towards metastasis, Nat Rev Cancer, 12, 425, 10.1038/nrc3265 Falkenberg, 2014, Histone deacetylases and their inhibitors in cancer, neurological diseases and immune disorders, Nat Rev Drug Discov, 13, 673, 10.1038/nrd4360 Truong, 2021, Entinostat induces antitumor immune responses through immune editing of tumor neoantigens, J Clin Invest, 131, e138560, 10.1172/JCI138560 Jiang, 2019, Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial, Lancet Oncol, 20, 806, 10.1016/S1470-2045(19)30164-0 Huang, 2019, Small molecule HDAC inhibitors: promising agents for breast cancer treatment, Bioorg Chem, 91, 10.1016/j.bioorg.2019.103184 Trapani, 2017, Entinostat for the treatment of breast cancer, Expet Opin Invest Drugs, 26, 965, 10.1080/13543784.2017.1353077 Connolly, 2017, Entinostat: a promising treatment option for patients with advanced breast cancer, Future Oncol, 13, 1137, 10.2217/fon-2016-0526 Masuda, 2021, Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer, BMC Cancer, 21, 1269, 10.1186/s12885-021-08973-4 Yardley, 2013, J Clin Oncol, 31, 2128, 10.1200/JCO.2012.43.7251 Connolly, 2021, E2112: randomized phase III trial of endocrine therapy plus entinostat or placebo in hormone receptor-positive advanced breast cancer. A trial of the ECOG-ACRIN cancer research group, J Clin Oncol, 39, 3171, 10.1200/JCO.21.00944 Hammond, 2010, American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version), Arch Pathol Lab Med, 134, e48, 10.5858/134.7.e48 Wolff, 2013, Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update, J Clin Oncol, 31, 3997, 10.1200/JCO.2013.50.9984 Zhang, 2020, Mechanisms of resistance to estrogen receptor modulators in ER+/HER2– advanced breast cancer, Cell Mol Life Sci, 77, 559, 10.1007/s00018-019-03281-4 Legare, 2016, Minireview: the link between eralpha corepressors and histone deacetylases in tamoxifen resistance in breast cancer, Mol Endocrinol, 30, 965, 10.1210/me.2016-1072 Sabnis, 2011, Functional activation of the estrogen receptor-α and aromatase by the HDAC inhibitor entinostat sensitizes ER-negative tumors to letrozole, Cancer Res, 71, 1893, 10.1158/0008-5472.CAN-10-2458 Leong, 2010, Is breast cancer the same disease in Asian and Western countries?, World J Surg, 34, 2308, 10.1007/s00268-010-0683-1 Hirko, 2022, The impact of race and ethnicity in breast cancer-disparities and implications for precision oncology, BMC Med, 20, 72, 10.1186/s12916-022-02260-0 Qiao, 2018, Prognostic and clinical significance of histone deacetylase 1 expression in breast cancer: a meta-analysis, Clin Chim Acta, 483, 209, 10.1016/j.cca.2018.05.005 Li, 2020, Clinical significance of HDAC1, -2 and -3 expression levels in esophageal squamous cell carcinoma, Exp Ther Med, 20, 315, 10.3892/etm.2020.8697 Pandey, 2019, Molecular mechanisms of resistance to CDK4/6 inhibitors in breast cancer: a review, Int J Cancer, 145, 1179, 10.1002/ijc.32020 Andre, 2021, Characterizing demographics, clinical, and genomic characteristics for US patients with HR+, HER2-metastatic breast cancer following progression on a CDK4 and 6 inhibitor, J Clin Oncol, 39, 1015, 10.1200/JCO.2021.39.15_suppl.1015