PMID- 37250148
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230531
IS  - 2211-3835 (Print)
IS  - 2211-3843 (Electronic)
IS  - 2211-3835 (Linking)
VI  - 13
IP  - 5
DP  - 2023 May
TI  - 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.
PG  - 2250-2258
LID - 10.1016/j.apsb.2023.02.001 [doi]
AB  - Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast 
      cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 
      trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese 
      patients with HR + ABC that relapsed/progressed after >/=1 endocrine therapy. 
      Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat 
      (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint 
      was the independent radiographic committee (IRC)-assessed progression-free 
      survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) 
      patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously 
      used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline 
      characteristics were comparable between the entinostat and placebo groups. The 
      median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in 
      the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), 
      respectively. Grade >/=3 adverse events (AEs) occurred in 154 (65.5%) patients in 
      the entinostat group versus 23 (19.3%) in the placebo group, and the most common 
      grade >/=3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia 
      [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly 
      improved PFS compared with exemestane, with generally manageable toxicities in 
      HR + ABC (ClinicalTrials.gov #NCT03538171).
CI  - (c) 2023 Chinese Pharmaceutical Association and Institute of Materia Medica, 
      Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.
FAU - Xu, Binghe
AU  - Xu B
AD  - Department of Medical Oncology and State Key Laboratory of Molecular Oncology, 
      National Cancer Cener/Cancer Hospital, Chinese Academy of Medical Sciences and 
      Peking Union Medical College, Beijing 100021, China.
FAU - Zhang, Qingyuan
AU  - Zhang Q
AD  - Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 
      150000, China.
FAU - Hu, Xichun
AU  - Hu X
AD  - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 
      200000, China.
FAU - Li, Qing
AU  - Li Q
AD  - Department of Medical Oncology and State Key Laboratory of Molecular Oncology, 
      National Cancer Cener/Cancer Hospital, Chinese Academy of Medical Sciences and 
      Peking Union Medical College, Beijing 100021, China.
FAU - Sun, Tao
AU  - Sun T
AD  - Department of Galactophore, Liaoning Cancer Hospital & Institute, Shenyang 
      110801, China.
FAU - Li, Wei
AU  - Li W
AD  - Department of Oncology, the First Hospital of Jilin University, Changchun 130061, 
      China.
FAU - Ouyang, Quchang
AU  - Ouyang Q
AD  - Department of Galactophore, Hunan Cancer Hospital, Changsha 410000, China.
FAU - Wang, Jingfen
AU  - Wang J
AD  - Department of Galactophore, Linyi Cancer Hospital, Linyi 276000, China.
FAU - Tong, Zhongsheng
AU  - Tong Z
AD  - Department of Breast Medical Oncology, Tianjin Medical University Cancer 
      Institute & Hospital, Tianjin 300000, China.
FAU - Yan, Min
AU  - Yan M
AD  - Department of Breast Disease, Henan Breast Cancer Center, the Affiliated Cancer 
      Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450008, 
      China.
FAU - Li, Huiping
AU  - Li H
AD  - Department of Breast Oncology, Beijing Cancer Hospital, Beijing 100000, China.
FAU - Zeng, Xiaohua
AU  - Zeng X
AD  - Breast Cancer Center, Chongqing University Cancer Hospital, Chongqing 400000, 
      China.
FAU - Shan, Changping
AU  - Shan C
AD  - Department of Breast and Thyroid Oncology, Affiliated Hospital of Jining Medical 
      University, Changchun 130021, China.
FAU - Wang, Xian
AU  - Wang X
AD  - Department of Medical Oncology, Run Run Shaw Hospital, Affiliated Hospital of 
      Zhejiang University, Hangzhou 310003, China.
FAU - Yan, Xi
AU  - Yan X
AD  - Department of Head and Heck Oncology, West China Hospital, Sichuan University, 
      Chengdu 610000, China.
FAU - Zhang, Jian
AU  - Zhang J
AD  - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 
      200000, China.
FAU - Zhang, Yue
AU  - Zhang Y
AD  - Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 
      150000, China.
FAU - Wang, Jiani
AU  - Wang J
AD  - Department of Medical Oncology and State Key Laboratory of Molecular Oncology, 
      National Cancer Cener/Cancer Hospital, Chinese Academy of Medical Sciences and 
      Peking Union Medical College, Beijing 100021, China.
FAU - Zhang, Liang
AU  - Zhang L
AD  - Department of Galactophore, Liaoning Cancer Hospital & Institute, Shenyang 
      110801, China.
FAU - Lin, Ying
AU  - Lin Y
AD  - Department of Thyroid & Breast Surgery, the First Affiliated Hospital of Sun 
      Yat-sen University, Guangzhou 510000, China.
FAU - Feng, Jifeng
AU  - Feng J
AD  - Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing 210000, China.
FAU - Chen, Qianjun
AU  - Chen Q
AD  - Department of Galactophore, Guangdong Hospital of Traditional Chinese Medicine, 
      Guangzhou 510000, China.
FAU - Huang, Jian
AU  - Huang J
AD  - Department of Oncological Surgery, the Second Affiliated Hospital, Zhejiang 
      University School of Medicine, Hangzhou 310000, China.
FAU - Zhang, Lu
AU  - Zhang L
AD  - Taizhou EOC Pharma Co., Ltd., Taizhou 318000, China.
FAU - Yang, Lisong
AU  - Yang L
AD  - Taizhou EOC Pharma Co., Ltd., Taizhou 318000, China.
FAU - Tian, Ying
AU  - Tian Y
AD  - Taizhou EOC Pharma Co., Ltd., Taizhou 318000, China.
FAU - Shang, Hongyan
AU  - Shang H
AD  - Taizhou EOC Pharma Co., Ltd., Taizhou 318000, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03538171
PT  - Clinical Trial
DEP - 20230209
PL  - Netherlands
TA  - Acta Pharm Sin B
JT  - Acta pharmaceutica Sinica. B
JID - 101600560
PMC - PMC10213795
OTO - NOTNLM
OT  - Advanced breast cancer
OT  - Histone deacetylase inhibitors
OT  - Hormone receptor-positive
OT  - Phase 3 clinical trial
EDAT- 2023/05/30 13:07
MHDA- 2023/05/30 13:08
PMCR- 2023/02/09
CRDT- 2023/05/30 11:20
PHST- 2022/08/22 00:00 [received]
PHST- 2022/12/06 00:00 [revised]
PHST- 2023/01/03 00:00 [accepted]
PHST- 2023/05/30 13:08 [medline]
PHST- 2023/05/30 13:07 [pubmed]
PHST- 2023/05/30 11:20 [entrez]
PHST- 2023/02/09 00:00 [pmc-release]
AID - S2211-3835(23)00028-X [pii]
AID - 10.1016/j.apsb.2023.02.001 [doi]
PST - ppublish
SO  - Acta Pharm Sin B. 2023 May;13(5):2250-2258. doi: 10.1016/j.apsb.2023.02.001. Epub 
      2023 Feb 9.