drugset / Trial / NCT02482753

Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer

NCT02482753 ↗

Phase 3 Completed 365 enrolled Chipscreen Biosciences, Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study was to evaluate the efficacy and safety of Chidamide in combination with exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.

Timeline

Start
2015-07
Primary completion
2018-03
Completion
2021-02

Outcome

Met primary endpoint

paper 7·4 months (95% CI 5·5-9·2) in the tucidinostat group and 3·8 months (3·7-5·5) in the placebo group (HR 0·75 [95% CI 0·58-0·98]; p=0·033). PMID 31036468 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tucidinostat Small molecule 30 mg Oral
Background Exemestane Small molecule 25 mg Oral

Indications