New hope for advanced breast cancer: experimental combo enters final testing

NCT ID NCT06680921

First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether an experimental drug called SIM0270 combined with everolimus works better than standard treatments for people with ER+/HER2- advanced or metastatic breast cancer that has worsened after CDK4/6 inhibitor therapy. About 460 participants will be randomly assigned to receive either the new combination or a doctor's choice of standard therapy. The main goal is to see if the new combination delays cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
SIM0270 (an experimental drug) combined with everolimus
What this could lead to
If successful, this could offer a new treatment option for people with ER+/HER2- advanced breast cancer whose disease has progressed after CDK4/6 inhibitor therapy.
What could go wrong
This is a Phase 3 trial, but the experimental combination may not improve progression-free survival or overall survival compared to standard treatments. Side effects from the combination could be significant.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, China

  • Anyang Tumor Hospital

    Anyang, Henan, China

  • Baoji Central Hospital

    Baoji, Shan'Xi, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, China

  • Binzhou Medical University Hospital

    Binzhou, Shandong, China

  • First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, China

  • First Hospital Of Qinhuangdao

    Qinhuangdao, Hebei, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

  • Fujian Provincial Hospital

    Fuzhou, Fujian, China

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, China

  • Guangdong Maternal and Child Health Hospital

    Guangzhou, Guangdong, China

  • Guangxi Medical University Cancer hospital

    Nanning, Guangxi, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, China

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, China

  • Jilin Cancer Hospital

    Changchun, Jilin, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, China

  • Linyi Cancer Hospital

    Linyi, Shandong, China

  • Linyi People'S Hostipal

    Linyi, Shandong, China

  • Maanshan People's Hospital

    Maanshan, Anhui, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan, Shandong, China

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

  • The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

    Zhengzhou, Henan, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan, China

  • The First Affiliated Hispital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hispital of Bengbu Medical University

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, China

  • The First Affiliated Hospital of JINZHOU Medical University

    Jinzhou, Liaoning, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Hospital of Jilin University

    Changchun, Jilin, China

  • The First Medical Center of PLA Ggeneral Hospital

    Beijing, Beijing Municipality, China

  • The First PEOPLE'S HOSPITAL OF CHANGDE CITY

    Changde, Hunan, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, China

  • Weifang People'S Hospital

    Weifang, Shandong, China

  • Weihai Municipal Hospital

    Weihai, Shandong, China

  • Wuhan University Zhongnan Hospital

    Wuhan, Hubei, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xiangyang Central Hospital

    Xiangyang, Hubei, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong, China

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Other studies related to the condition(s) this trial covers.