A Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
研究单位：[1]Chia Tai Tianqing Pharmaceutical Group Co., Ltd.[2]The First Affiliated Hospital of Bengbu Medical University,Bengbu,Anhui,China,233004[3]AnHui Province Hospital West District,Hefei,Anhui,China,230000[4]The first Affiliated hospital of anhui medical university,Hefei,Anhui,China,230000[5]Beijing Cancer Hospital,Beijing,Beijing,China,100142[6]Fujian Medical University 2nd Affiliated Hospital,Quanzhou,Fujian,China,362000[7]Zhangzhou Hospital in Fujian Province,Zhangzhou,Fujian,China,363000[8]Gansu Provincial Hospital,Lanzhou,Gansu,China,730000[9]Gansu Provincial Cancer Hospital,Lanzhou,Gansu,China,730050[10]Gansu Wuwei Tumour Hospital,Wuwei,Gansu,China,730000[11]Sun Yet-Sen University Cancer Certer,Guangzhou,Guangdong,China,510000[12]Affiliated Hospital of Guangdong Medical University,ZhanJiang,Guangdong,China,524001[13]Guigang City People'S Hospital,Guigang,Guangxi,China,537100[14]Cancer Hospital Affiliated to Guangxi Medical University,Nanning,Guangxi,China,530021[15]The First affiliated hospital of GuangXi medical university,Nanning,Guangxi,China,530021[16]The Affiliated Cancer Hospital of Guizhou Medical University Co., LTD,Guiyang,Guizhou,China,550000[17]Guizhou Provincial People's Hospital,Guiyang,Guizhou,China,550002[18]The First Affiliated Hospital of Hainan Medical College,Haikou,Hainan,China,570102[19]Hainan General Hospital,Haikou,Hainan,China,570311[20]Affiliated Hospital of Hebei University,Baoding,Hebei,China[21]Chengde Central Hospital,Chengde,Hebei,China,067024[22]Affiliated Cancer Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150081[23]AnYang Tumor Hospital,Anyang,Henan,China,455100[24]Henan Cancar Hospital,Zhengzhou,Henan,China,450000[25]The First Affiliated Hospital of Henan University of Science & Technology,Luoyang,Hennan,China,471003[26]Tongji Hospital Tongji Medical College of HUST,Wuhan,Hubei,China,430034[27]Hubei Cancer Hospital,Wuhan,Hubei,China,430079[28]Chifeng Municipal Hospital,Chifeng,Inner Mongolia,China,24099[29]The Second Hospital of DALIAN Medical University,Dalian,Liaoning,China,116000[30]Binzhou Medical College Affiliated Hospital,Binzhou,Shandong,China,256699[31]Binzhou People's Hospital,Binzhou,Shandong,China,310053[32]Obstetrics & Gynecology Hospital of Fudan University,Shanghai,Shanghai,China,200082[33]Baoji Central Hospital,Baoji,Shanxi,China,721008[34]Affiliated Hospital of North Scichuan Medical College,Nanchong,Sichuan,China,637000[35]Affiliated Hangzhou First People's Hospital,Hangzhou,Zhejiang,China,310004
研究目的：
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. The primary objective of the study is to determine the efficacy and safety of TQB2102 compared to investigator-selected single-agent chemotherapy in the target population. 542 subjects with HER2 immunohistochemistry (IHC )2+/ in situ hybridization (ISH)- and IHC 1+ (HER2-low) expression will be enrolled in 1:1 randomized groups to receive TQB2102 or investigator's choice of single-agent chemotherapy (capecitabine, paclitaxel, or albumin-paclitaxel) until progression of disease (PD), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1. 1, unless there are unacceptable toxicity, withdrawal of consent, or meeting other discontinuation criteria.
