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Locally Advanced or Metastatic Breast CancerPhase 3NCT06680921

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

A Phase 3 study testing SIM0270, Everolimus (Afinitor®) and Exemestane tablets in people with Locally Advanced or Metastatic Breast Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 57 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SIM0270, Everolimus (Afinitor®) and Exemestane tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
57 sitesChina
Study dates
14 Nov 2024to 31 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

China57 sites

  • Anyang Tumor Hospital

    Anyang, Henan

  • Baoji Central Hospital

    Baoji, Shan'Xi

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • The First Medical Center of PLA Ggeneral Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hispital of Bengbu Medical University

    Bengbu, Anhui

  • Binzhou Medical University Hospital

    Binzhou, Shandong

  • Jilin Cancer Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The First PEOPLE'S HOSPITAL OF CHANGDE CITY

    Changde, Hunan

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Fujian Provincial Hospital

    Fuzhou, Fujian

  • Guangdong Maternal and Child Health Hospital

    Guangzhou, Guangdong

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

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

  • The First Affiliated Hispital of Anhui Medical University

    Hefei, Anhui

  • Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan, Shandong

  • The First Affiliated Hospital of JINZHOU Medical University

    Jinzhou, Liaoning

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Linyi People'S Hostipal

    Linyi, Shandong

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

    Luoyang, Henan

  • Maanshan People's Hospital

    Maanshan, Anhui

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Guangxi Medical University Cancer hospital

    Nanning, Guangxi

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • First Hospital Of Qinhuangdao

    Qinhuangdao, Hebei

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Weifang People'S Hospital

    Weifang, Shandong

  • Weihai Municipal Hospital

    Weihai, Shandong

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Wuhan University Zhongnan Hospital

    Wuhan, Hubei

  • First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi

  • Xiangyang Central Hospital

    Xiangyang, Hubei

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan

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

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong

Other trials in China

About this study

Official title: 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

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.

Being tested
SIM0270, Everolimus (Afinitor®), Exemestane tablets, Fulvestrant injection
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIM0270Drug

    Experimental

  • Everolimus (Afinitor®)Drug

    Experimental and Active comparator

  • Exemestane tabletsDrug

    Active Comparator

  • Fulvestrant injectionDrug

    Active Comparator

Study groups in NCT06680921
Study groupRoleWhat they receive
Experimental groupExperimentalSIM0270 to be taken orally as a capsule in combination with Everolimus.
Receives: Drug: SIM0270; Drug: Everolimus (Afinitor®)
Control groupActive 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.
Receives: Drug: Everolimus (Afinitor®); Drug: Exemestane tablets; Drug: Fulvestrant injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 year

Secondary outcomes (14)

  1. Progression free survival(PFS) , as assessed by investigator 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.

    Measured: 2 year

  2. Overall Survival (OS)

    OS is the time from the date of randomization to death from any cause.

    Measured: 3 year

  3. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0

    Measured: 3 year

  4. Blood concentrations

    Blood concentrations of SIM0270 and everolimus

    Measured: At five specified time points of the first 6 cycles (each cycle is 28 days)

  5. Objective Response Rate (ORR) by investigator

    The objective response rate is defined as the percentage of subjects with a complete response or partial response.

    Measured: 2 year

  6. Objective Response Rate (DOR) by investigator

    The DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause.

    Measured: 2 year

  7. ORR by BIRC

    The objective response rate is defined as the percentage of subjects with a complete response or partial response.

    Measured: 2 year

  8. DOR by BIRC

    The DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause.

    Measured: 2 year

  9. Clinical benefit rate(CBR) by investigator

    The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks.

    Measured: 2 year

  10. CBR by BIRC

    The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks.

    Measured: 2 year

  11. Time To Progression (TTP) by investigator

    TTP is defined as the time from randomization until the date of first documented progression.

    Measured: 2 year

  12. Time To Progression (TTP) by BIRC

    TTP is defined as the time from randomization until the date of first documented progression.

    Measured: 2 year

  13. Change from baseline in EQ-5D-5L scores

    Change from baseline in EQ-5D-5L scores

    Measured: 2 year

  14. Change from baseline in FACT-B scores

    Change from baseline in FACT-B scores

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start14 Nov 2024
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680921
Sponsor's protocol ID
SIM0270-301
Status last verified
Aug 2026
First submitted
5 Nov 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SIM0270, Everolimus (Afinitor®) and Exemestane tablets in people with Locally Advanced or Metastatic Breast Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 57 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1 (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06680921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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