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

NCT ID NCT06680921

Disease control Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

482 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer 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: 1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Locally advanced or metastatic breast cancer

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

More trials for these conditions

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