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A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.
Official title: A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated , ER+/HER2- Locally Advanced or Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2024-11-14
Completion Date
2028-08-31
Last Updated
2025-09-22
Healthy Volunteers
No
Interventions
SIM0270
Experimental
Everolimus (Afinitor®)
Experimental and Active comparator
Exemestane tablets
Active Comparator
Fulvestrant injection
Active Comparator
Locations (60)
The First Affiliated Hispital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hispital of Anhui Medical University
Hefei, Anhui, China
Maanshan People's Hospital
Maanshan, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Medical Center of PLA Ggeneral Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Guangdong Maternal and Child Health Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Guangxi Medical University Cancer hospital
Nanning, Guangxi, China
First Hospital Of Qinhuangdao
Qinhuangdao, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Wuhan University Zhongnan Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The First PEOPLE'S HOSPITAL OF CHANGDE CITY
Changde, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of JINZHOU Medical University
Jinzhou, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Baoji Central Hospital
Baoji, Shan'Xi, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Linyi People'S Hostipal
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People'S Hospital
Weifang, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China