Spots Global Cancer Trial Database for To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
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Trial Identification
Brief Title: To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
Official Title: A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer
Study ID: NCT05365178
Study Description
Brief Summary: A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant injection (experimental group) or placebo capsule combined with fulvestrant (control group). A total of 428 subjects were required.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Peking University First Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
The Southwest Hospital of AMU, Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Gansu Provincial Cancer Hospital, Lanzhou, Gansu, China
Lanzhou University Second Hospital, Lanzhou, Gansu, China
Gansu Wuwei Tumour Hospital, Wuwei, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University, Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
Jieyang People's Hospital, Jieyang, Guangdong, China
Maoming people's hospital, Maoming, Guangdong, China
Yue Bei People's Hospital, Shaoguan, Guangdong, China
ShenZhen People's Hospital, Shenzhen, Guangdong, China
PeKing University ShenZhen Hosipital, Shenzhen, Guangdong, China
Zhongshan City People's Hospital, Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China
Yulin First People's Hospital, Yulin, Guangxi, China
The Affiliated Hospital of Hebei University, Baoding, Hebei, China
Cangzhou Central Hospital, Cangzhou, Hebei, China
Hebei Cangzhou Hospital of Integrated Traditional Chinese, Cangzhou, Hebei, China
Affiliated Hospital of Chengde Medical University, Chengde, Hebei, China
Hebei Petro China Central Hospital, Langfang, Hebei, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Jiamusi Cancer Hospital, Jiamusi, Heilongjiang, China
Luoyang Central Hospital, Luoyang, Henan, China
Nanyang Central Hospital, Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Yichang Central People's Hospital, Yichang, Hubei, China
The First People's Hospital of Changde, Changde, Hunan, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Xiangya Hospital of Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Changzhou Cancer Hospital, Changzhou, Jiangsu, China
Huai'an First People's Hospital, Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Jiangsu province hospital, Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University, Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University, Ganzhou, Jiangxi, China
The Third Hospital of Nanchang, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Second Hospital of Jilin University, Changchun, Jilin, China
The Second Hosptial of DaLian Medical University, Dalian, Liaoning, China
Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Affiliated Hospital of Chifeng University, Chifeng, Neimenggu, China
Inner Mongolia Autonomous Region Cancer Hospital, Hohhot, Neimenggu, China
The Affilliate Hospital of Inner Mongolia Medical Univercity, Hohhot, Neimenggu, China
General Hospital of Ningxia Medical, Yinchuan, Ningxia, China
Qinghai University affiliated hospital, Xining, Qinghai, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
First Affiliated University Hospital of PLA Air Force Military Medical, Xi'an, Shaanxi, China
Second Affiliated Hospital of PLA Air Force Military Medical, Xi'an, Shaanxi, China
Xi'an International Medical Center Hospital, Xi'an, Shaanxi, China
Binzhou Medical College Affiliated Hospital, Binzhou, Shandong, China
Shandong Cancer Hospital, Jinan, Shandong, China
Affiliated Hospital of Jining Medical University, Jining, Shandong, China
Linyin Cancer Hospital, Linyi, Shandong, China
Qingdao University Affiliated Hospital, Qingdao, Shandong, China
Weifang Hospital of Traditional Chinese Midicine, Weifang, Shandong, China
Yantai Yantai Mountain hospital, Yantai, Shandong, China
Zibo Central Hospital, Zibo, Shandong, China
Huadong Hospital, Shanghai, Shanghai, China
Shanghai Oriental Hospital, Shanghai, Shanghai, China
Shanghai Changhai Hospital, Shanghai, Shanghai, China
Changzhi People's Hospital, Changzhi, Shanxi, China
Shanxi Cancer Hospital, Taiyuan, Shanxi, China
Chinese People's Liberation Army Western Theater General Hospital, Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
Suining Central Hospital, Suining, Sichuan, China
Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, China
Tianjin Medical University Cancer Hospital Konggang Hospital, Tianjin, Tianjin, China
Cancer Hospital affiliated to Xinjiang Medical University, Urumqi, Xinjiang, China
Yunnan Cancel Hospital, Kunming, Yunan, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medcine, Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
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