RecruitingPhase 3NCT06680921

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

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

460 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Locally Advanced or Metastatic Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a new drug (SIM0270, which blocks a pathway that helps cancer cells grow) combined with everolimus (another cancer drug) works better than a doctor's chosen standard therapy for people with hormone receptor-positive, HER2-negative advanced breast cancer that has progressed on prior treatments. **You may be eligible if...** - You have been diagnosed with ER-positive, HER2-negative locally advanced or metastatic breast cancer (confirmed by biopsy) - You have measurable disease on scans or bone lesions - Your cancer has grown after 1–2 previous hormonal therapies for advanced disease - You have received a CDK4/6 inhibitor as part of prior treatment **You may NOT be eligible if...** - You have not received prior endocrine (hormonal) therapy - You have received more than 2 lines of chemotherapy for advanced/metastatic disease - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSIM0270

Experimental

DRUGEverolimus (Afinitor®)

Experimental and Active comparator

DRUGExemestane tablets

Active Comparator

DRUGFulvestrant 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

View Full Details on ClinicalTrials.gov

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NCT06680921

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