A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
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
1 other identifier
interventional
460
1 country
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2024
Typical duration for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 8, 2024
CompletedStudy Start
First participant enrolled
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
September 22, 2025
September 1, 2025
3.8 years
November 5, 2024
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1
PFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first.
2 year
Secondary Outcomes (14)
Progression free survival(PFS) , as assessed by investigator according to RECIST1.1
2 year
Overall Survival (OS)
3 year
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
3 year
Blood concentrations
At five specified time points of the first 6 cycles (each cycle is 28 days)
Objective Response Rate (ORR) by investigator
2 year
- +9 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALSIM0270 to be taken orally as a capsule in combination with Everolimus.
Control group
ACTIVE COMPARATORInvestigator'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.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
- Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
- 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
- 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.
- Eastern Cooperative Oncology Group Performance Status 0-1
- Adequate organ function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 200032, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 8, 2024
Study Start
November 14, 2024
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
September 22, 2025
Record last verified: 2025-09