Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Summary

The primary objective of this study is to investigate the effect of 5 mg KHK2375 on progression free survival (PFS) when administered orally at weekly intervals in combination with exemestane in a placebo-controlled, double-blind comparative study in subjects with advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are to investigate the effect of on overall survival (OS) and the antitumor effect and to evaluate the pharmacokinetics and safety.

Timeline

Start

2017-09-22

Primary completion

2019-04-04

Completion

2021-03-26

Publications

• Iwata H, Nakamura R, Masuda N, Yamashita T, Yamamoto Y, Kobayashi K, Tsurutani J, Iwasa T, Yonemori K, Tamura K, Aruga T, Tokunaga E, Kaneko K, Lee MJ, Yuno A, Kawabata A, Seike T, Kaneda A, Nishimura Y, Trepel JB, Saji S. Efficacy and exploratory biomarker analysis of entinostat plus exemestane in advanced or recurrent breast cancer: phase II randomized controlled trial. Jpn J Clin Oncol. 2023 Jan 6;53(1):4-15. doi: 10.1093/jjco/hyac166.

Drugs

Indications