NCT02482753

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

A Phase III Trial of Chidamide in Combination With Exemestane in Patients With Hormone Receptor-Positive Advanced Breast Cancer (ACE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study including two parts: (1) Part A, open-label design, 20 patients will be enrolled and receive 30 mg Chidamide BIW and 25 mg exemestane QD. The main object of part A is to evaluate the pharmacokinetic and pharmacodynamic profile of Chidamide when in combination with exemestane. (2) Part B, randomized and double-blinded design, 328 patients will be assigned randomly in a 2:1 ratio to experiment group (30 mg Chidamide BIW + 25 mg exemestane QD) and control group (placebo BIW + 25 mg exemestane QD), to evaluate the efficacy and safety of Chidamide when in combination with exemestane in patients with locally advanced or metastatic estrogen receptor-positive breast cancer progressing on endocrine therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Chidamide	30 mg, administered orally twice per week (BIW)
DRUG	exemestane	25 mg, PO daily
DRUG	placebo	Administered orally twice per week (BIW)

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-03-01
• Completion: 2021-02-01
• First posted: 2015-06-26
• Last updated: 2022-01-12

Locations

22 sites across 1 country: China