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
研究单位：[1]Chia Tai Tianqing Pharmaceutical Group Co., Ltd.[2]The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui,China,233099[3]The First Affiliated Hospital of Wannan Medical College,Wuhu,Anhui,China,241000[4]Peking University First Hospital,Beijing,Beijing,China,100034[5]Beijing Cancer Hospital,Beijing,Beijing,China,100142[6]Chongqing University Cancer Hospital,Chongqing,Chongqing,China,400000[7]The Southwest Hospital of AMU,Chongqing,Chongqing,China,400083[8]Fujian Provincial Cancer Hospital,Fuzhou,Fujian,China,350014[9]Gansu Provincial Cancer Hospital,Lanzhou,Gansu,China,730000[10]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730030[11]Gansu Wuwei Tumour Hospital,Wuwei,Gansu,China,730000[12]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510060[13]Nanfang Hospital Southern Medical University,Guangzhou,Guangdong,China,510080[14]The Third Affiliated Hospital of Sun Yat-Sen University,Guangzhou,Guangdong,China,510630[15]Jieyang People's Hospital,Jieyang,Guangdong,China,522095[16]Maoming people's hospital,Maoming,Guangdong,China,525000[17]Yue Bei People's Hospital,Shaoguan,Guangdong,China,512025[18]ShenZhen People's Hospital,Shenzhen,Guangdong,China,518020[19]PeKing University ShenZhen Hosipital,Shenzhen,Guangdong,China,518036[20]Zhongshan City People's Hospital,Zhongshan,Guangdong,China,528403[21]The Fifth Affiliated Hospital of Sun Yat-Sen University,Zhuhai,Guangdong,China,519099[22]The Second Affiliated Hospital of Guilin Medical University,Guilin,Guangxi,China,541199[23]Yulin First People's Hospital,Yulin,Guangxi,China,537000[24]The Affiliated Hospital of Hebei University,Baoding,Hebei,China,071000[25]Cangzhou Central Hospital,Cangzhou,Hebei,China,061013[26]Hebei Cangzhou Hospital of Integrated Traditional Chinese,Cangzhou,Hebei,China,061013[27]Affiliated Hospital of Chengde Medical University,Chengde,Hebei,China,067020[28]Hebei Petro China Central Hospital,Langfang,Hebei,China,065000[29]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050011[30]Affiliated Cancer Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150081[31]The Second Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150086[32]Jiamusi Cancer Hospital,Jiamusi,Heilongjiang,China,154007[33]Luoyang Central Hospital,Luoyang,Henan,China,471003[34]Nanyang Central Hospital,Nanyang,Henan,China,473000[35]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052[36]Henan Cancer Hospital,Zhengzhou,Henan,China,45008[37]Yichang Central People's Hospital,Yichang,Hubei,China,443003[38]The First People's Hospital of Changde,Changde,Hunan,China,415003[39]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China,410000[40]Xiangya Hospital of Central South University,Changsha,Hunan,China,410000[41]Hunan Cancer Hospital,Changsha,Hunan,China,410031[42]Changzhou Cancer Hospital,Changzhou,Jiangsu,China,213000[43]Huai'an First People's Hospital,Huai'an,Jiangsu,China,223300[44]Nanjing Drum Tower Hospital,Nanjing,Jiangsu,China,210008[45]Jiangsu province hospital,Nanjing,Jiangsu,China,210029[46]Affiliated Hospital of Nantong University,Nantong,Jiangsu,China,226001[47]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China,221004[48]The First Affiliated Hospital of Gannan Medical University,Ganzhou,Jiangxi,China,341099[49]The Third Hospital of Nanchang,Nanchang,Jiangxi,China,330000[50]Jilin Cancer Hospital,Changchun,Jilin,China,130012[51]The First Hospital of Jilin University,Changchun,Jilin,China,130021[52]Second Hospital of Jilin University,Changchun,Jilin,China,130041[53]The Second Hosptial of DaLian Medical University,Dalian,Liaoning,China,116000[54]Affiliated Zhongshan Hospital of Dalian University,Dalian,Liaoning,China,116001[55]The First Affiliated Hospital of Jinzhou Medical University,Jinzhou,Liaoning,China,121012[56]The First Affiliated Hospital of China Medical University,Shenyang,Liaoning,China,1100
研究目的：
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.
