Actively Recruiting
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-09-22
460
Participants Needed
60
Research Sites
198 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead Sponsor
N
Nanjing Zaiming Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion criteria:
-
Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
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Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
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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
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Have disease that has demonstrated progression on or after prior treatment:
- 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
- subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
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Eastern Cooperative Oncology Group Performance Status 0-1
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Adequate organ function
exclusion criteria:
- Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors
- 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
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
- Pregnant or breastfeeding
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 60 locations
1
The First Affiliated Hispital of Bengbu Medical University
Bengbu, Anhui, China
Actively Recruiting
2
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Actively Recruiting
3
The First Affiliated Hispital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
4
Maanshan People's Hospital
Maanshan, Anhui, China
Actively Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
6
The First Medical Center of PLA Ggeneral Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
7
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
8
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
9
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
10
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
11
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Not Yet Recruiting
12
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Actively Recruiting
13
Guangdong Maternal and Child Health Hospital
Guangzhou, Guangdong, China
Actively Recruiting
14
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
15
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
16
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Actively Recruiting
17
Guangxi Medical University Cancer hospital
Nanning, Guangxi, China
Actively Recruiting
18
First Hospital Of Qinhuangdao
Qinhuangdao, Hebei, China
Actively Recruiting
19
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
20
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
21
Anyang Tumor Hospital
Anyang, Henan, China
Actively Recruiting
22
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
23
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
24
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
25
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
26
Wuhan Central Hospital
Wuhan, Hubei, China
Actively Recruiting
27
Wuhan University Zhongnan Hospital
Wuhan, Hubei, China
Not Yet Recruiting
28
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
29
The First PEOPLE'S HOSPITAL OF CHANGDE CITY
Changde, Hunan, China
Actively Recruiting
30
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
31
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
32
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Actively Recruiting
33
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
34
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
35
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
36
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
37
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
38
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
39
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
40
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
41
The First Affiliated Hospital of JINZHOU Medical University
Jinzhou, Liaoning, China
Not Yet Recruiting
42
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
43
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
44
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
45
Baoji Central Hospital
Baoji, Shan'Xi, China
Actively Recruiting
46
Binzhou Medical University Hospital
Binzhou, Shandong, China
Not Yet Recruiting
47
Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China
Actively Recruiting
48
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
49
Linyi People'S Hostipal
Linyi, Shandong, China
Actively Recruiting
50
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
51
Weifang People'S Hospital
Weifang, Shandong, China
Actively Recruiting
52
Weihai Municipal Hospital
Weihai, Shandong, China
Actively Recruiting
53
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
54
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
55
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
56
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
57
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
58
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
59
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
60
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
J
JING WANG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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