Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

Summary

The purpose of this randomized phase III trial is to evaluate the clinical benefit of combining entinostat with exemestane in Chinese patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer, who have disease progression on endocrine therapy. Additionally，the safety, tolerability, and PK profile of the treatment combination are evaluated.

Timeline

Start

2018-05-15

Primary completion

2021-07

Completion

2023-03

Publications

• Xu B, Zhang Q, Hu X, Li Q, Sun T, Li W, Ouyang Q, Wang J, Tong Z, Yan M, Li H, Zeng X, Shan C, Wang X, Yan X, Zhang J, Zhang Y, Wang J, Zhang L, Lin Y, Feng J, Chen Q, Huang J, Zhang L, Yang L, Tian Y, Shang H. 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. Acta Pharm Sin B. 2023 May;13(5):2250-2258. doi: 10.1016/j.apsb.2023.02.001. Epub 2023 Feb 9.

Drugs

Indications