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

Advanced Breast Cancer Clinical Trial

Official title:
A Randomized Phase III Clinical Study of Entinostat/Placebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer

Clinical Trial 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.

Clinical Trial Description

This randomized phase III trial studies entinostat combination with exemestane to see how well they work compared to exemestane alone in treating Chinese patients with hormone receptor-positive, locally advanced or metastatic breast cancers. Estrogen can drive the growth of breast cancer cells. Exemestane may fight breast cancer by lowering the amount of estrogen the body makes from tissue aromatase. Entinostat may enhance the anti-tumor effect of exemestane in breast cancer by helping to overcome tumor resistance via epigenetic modifications. Previous Phase II trial in US breast cancer patients have demonstrated significant effects of combined therapy in slowing disease progression and on patient survival when compared to exemestane alone. It is not yet known whether exemestane is more effective when combined with entinostat in Chinese patients with advanced breast cancer. In this parallel, randomized, double blind, active controlled study, we will study the effect of entinostat/placebo in combination with exemestane in Chinese patients with hormone receptor-positive, HER2 receptor-negative, locally advance or metastatic breast cancer, who have experienced disease progression with prior endocrine therapies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03538171
Study type Interventional
Source Taizhou EOC Pharma Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 15, 2018
Completion date March 2023
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