Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
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研究单位:[1]Jiangsu HengRui Medicine Co., Ltd.[2]The Fifth Medical Center of Chinese PLA General Hospital Beijing, Beijing, China, 100071[3]Fujian Medical University Union Hospital Fuzhou, Fujian, China, 350001[4]Sun Yet-Sen University Cancer Center Guangzhou, Guangdong, China, 510010[5]Guangdong Provincial People's Hospital Guangzhou, Guangdong, China, 510080[6]Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou, Guangdong, China, 510289[7]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050000河北医科大学第四医院[8]The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital Zhengzhou, Henan, China, 450000[9]Huai'an First People's Hospital Huaian, Jiangsu, China, 223001[10]JiangSu Province Hospital Nanjing, Jiangsu, China, 210029[11]Shandong Cancer Hospital Jinan, Shandong, China, 250000[12]The Affiliated Hospital Of Qingdao University Qingdao, Shandong, China, 266100[13]Fudan University Shanghai Cancer Center Shanghai, Shanghai, China, 200032[14]The Second Affiliated Hospital Of Xi'an Jiaotong University Xian, Shanxi, China, 710004[15]The First Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang, China, 310003[16]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310005[17]The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang, China, 310009[18]Peking University People's Hospital Beijing, Beijing, China, 100044
研究目的:
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.