Spots Global Cancer Trial Database for Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer
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Trial Identification
Brief Title: Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer
Official Title: A Phase III Trial of Chidamide in Combination With Exemestane in Patients With Hormone Receptor-Positive Advanced Breast Cancer (ACE)
Study ID: NCT02482753
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
The 307th Hospital of Chinese people's Liberation Army, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
Cangzhou Central Hospital, Cangzhou, Hebei, China
Tumor Hospital of Hebei Province, Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital, Ha'erbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Zhejiang Cancer Hospital, Hangzhou, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The Third Hospital of Nanchang, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Jinan Central Hospital, Jinan, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Fudan University ZhongShan Hospital, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Contact Details
Name: Zefei Jiang
Affiliation: 307 Hospital of PLA
Role: PRINCIPAL_INVESTIGATOR
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