A Study of BL-M07D1 + Pertuzumab With or Without Taxane Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
研究单位:[1]Sichuan Baili Pharmaceutical Co., Ltd.[2]Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.[3]The First Affiliated Hospital of Bengbu Medical University,Bengbu,Anhui,China[4]Anhui Provincial Cancer Hospital,Hefei,Anhui,China[5]The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital),Hefei,Anhui,China[6]The First Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China[7]Fujian Medical University Union Hospital,Fuzhou,Fujian,China[8]Guangdong Maternal and Child Health Center,Guangzhou,Guangdong,China[9]Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,Guangzhou,Guangdong,China[10]Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center,Shenzhen,Guangdong,China[11]Liuzhou People''s Hospital,Liuzhou,Guangxi,China[12]Guangxi Medical University Cancer Hospital,Nanning,Guangxi,China[13]Hainan General Hospital,Haikou,Hainan,China[14]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China[15]Xingtai People''s Hospital,Xingtai,Hebei,China[16]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China[17]Anyang Cancer Hospital,Anyang,Henan,China[18]The First Affiliated Hospital of Henan University of science and technology,Luoyang,Henan,China[19]Henan Provincial People''s Hospital,Zhengzhou,Henan,China[20]Hunan Cancer Hospital,Changsha,Hunan,China[21]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China[22]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China[23]Shaanxi Provincial People''s Hospital,Xi''an,Shaanxi,China[24]The First Affiliated Hospital of Xi''an Jiaotong University,Xi''an,Shaanxi,China[25]Shandong Cancer Hospital,Jinan,Shandong,China[26]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China[27]Shanxi Bethune Hospital,Taiyuan,Shanxi,China[28]Shanxi Cancer Hospital,Taiyuan,Shanxi,China[29]Sichuan Cancer Hospital,Chengdu,Sichuan,China[30]Tianjin Cancer Hospital,Tianjin,Tianjin,China[31]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,Zhejiang,China[32]Zhejiang Cancer Hospital,Hangzhou,Zhejiang,China
This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 + Pertuzumab in combination with or without taxane regimen in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).