A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
NCT ID: NCT06680921
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
460 participants
INTERVENTIONAL
2024-11-14
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
SIM0270 to be taken orally as a capsule in combination with Everolimus.
SIM0270
Experimental
Everolimus (Afinitor®)
Experimental and Active comparator
Control group
Investigator's choice of therapy of either:
Fulvestrant alone (a solution for injection), or Everolimus in combination with exemestane, both a tablet to be taken orally.
Everolimus (Afinitor®)
Experimental and Active comparator
Exemestane tablets
Active Comparator
Fulvestrant injection
Active Comparator
Interventions
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SIM0270
Experimental
Everolimus (Afinitor®)
Experimental and Active comparator
Exemestane tablets
Active Comparator
Fulvestrant injection
Active Comparator
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
3. For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment
4. Have disease that has demonstrated progression on or after prior treatment:
1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy
2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
5. Eastern Cooperative Oncology Group Performance Status 0-1
6. Adequate organ function
Exclusion Criteria
2. Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate/strong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate/strong CYP3A inducer within 28 days prior to first dose
3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
4. Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
6. Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Nanjing Zaiming Pharmaceutical Co., Ltd.
INDUSTRY
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Tingjing Yao
Role: primary
Yueyin Pan
Role: primary
Ying Dai
Role: primary
Dequan Ding
Role: primary
Huiping Li
Role: primary
Weihong Zhao
Role: primary
Lu Gan
Role: primary
Guobing Yin
Role: primary
Chuangui Song
Role: primary
Zhenhua Liu
Role: primary
Jianqing Lin
Role: primary
Yingxia Tian
Role: primary
Anqin Zhang
Role: primary
Ying Wang
Role: primary
Shusen Wang
Role: primary
Shihui Ma
Role: primary
Weimin Xie
Role: primary
Meng Han
Role: primary
Yunjiang Liu
Role: primary
Qingyuan Zhang
Role: primary
Jing Sun
Role: primary
Xinshuai Wang
Role: primary
Hongqiang Guo
Role: primary
Hong Zong
Role: primary
Xinhong Wu
Role: primary
Ming Jiang
Role: primary
Haijun Yan
Role: primary
Yuehua Wang
Role: primary
Tao Wu
Role: primary
Quchang Ouyang
Role: primary
Jun Huang
Role: primary
Sijuan Ding
Role: primary
Yuan Yuan
Role: primary
Li Xie
Role: primary
Yongmei Yin
Role: primary
Yanhua Liu
Role: primary
Zhengkui Sun
Role: primary
Chunjiao Wu
Role: primary
Lihua Kang
Role: primary
Man Li
Role: primary
Zhenhua Zhai
Role: primary
Tao Sun
Role: primary
Yuee Teng
Role: primary
Jin Yang
Role: primary
Youhuai Li
Role: primary
Fangling Ning
Role: primary
Yongsheng Wang
Role: primary
Jingfen Wang
Role: primary
Yongli Gao
Role: primary
Wenfeng Li
Role: primary
Wenhui Wang
Role: primary
Hongyan Xu
Role: primary
Chuxin Qin
Role: backup
Jinsong Lu
Role: primary
Qi Li
Role: primary
Hui Li
Role: primary
Yehui Shi
Role: primary
Yabing Zheng
Role: primary
Xuli Meng
Role: primary
Weizhu Wu
Role: primary
Other Identifiers
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SIM0270-301
Identifier Type: -
Identifier Source: org_study_id
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