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

September 18, 2025 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hispital of Bengbu Medical University
        • Contact:
          • Tingjing Yao
          • Phone Number: +86 13855200468
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Yueyin Pan
          • Phone Number: +86 13805695536
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hispital of Anhui Medical University
        • Contact:
          • Ying Dai
          • Phone Number: +86 13856031252
      • Maanshan, Anhui, China
        • Recruiting
        • Maanshan People's Hospital
        • Contact:
          • Dequan Ding
          • Phone Number: +86 18055569797
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Huiping Li
          • Phone Number: +86 13811012595
      • Beijing, Beijing Municipality, China
        • Recruiting
        • The First Medical Center of PLA Ggeneral Hospital
        • Contact:
          • Weihong Zhao
          • Phone Number: +86 15910853879
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Lu Gan
          • Phone Number: +86 18602320222
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Guobing Yin
          • Phone Number: +86 15823267119
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Chuangui Song
          • Phone Number: +86 13960709993
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
          • Zhenhua Liu
          • Phone Number: +86 13850118018
      • Quanzhou, Fujian, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Fujian Medical University
        • Contact:
          • Jianqing Lin
          • Phone Number: +86 13905977336
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Yingxia Tian
          • Phone Number: +86 13919451841
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Shusen Wang
          • Phone Number: +86 13926168469
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
          • Ying Wang
          • Phone Number: +86 13925038181
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Maternal and Child Health Hospital
        • Contact:
          • Anqin Zhang
          • Phone Number: +86 13925115929
      • Zhongshan, Guangdong, China
        • Recruiting
        • Zhongshan City People's Hospital
        • Contact:
          • Shihui Ma
          • Phone Number: +86 13620394254
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Weimin Xie
          • Phone Number: +86 13907861028
    • Hebei
      • Qinhuangdao, Hebei, China
        • Recruiting
        • First Hospital of Qinhuangdao
        • Contact:
          • Meng Han
          • Phone Number: +86 13333335237
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Yunjiang Liu
          • Phone Number: +86 13703297890
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Qingyuan Zhang
          • Phone Number: +86 13313612989
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • AnYang Tumor Hospital
        • Contact:
          • Jing Sun
          • Phone Number: +86 13939995116
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
          • Xinshuai Wang
          • Phone Number: +86 13837986128
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Hong Zong
          • Phone Number: +86 13523586882
      • Zhengzhou, Henan, China
        • Recruiting
        • The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
        • Contact:
          • Hongqiang Guo
          • Phone Number: +86 15188329236
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Xinhong Wu
          • Phone Number: +86 18602726300
      • Wuhan, Hubei, China
        • Recruiting
        • Wuhan Central Hospital
        • Contact:
          • Ming Jiang
          • Phone Number: +86 13907174950
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan University Zhongnan Hospital
        • Contact:
          • Haijun Yan
          • Phone Number: +86 13907174950
      • Xiangyang, Hubei, China
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
          • Yuehua Wang
          • Phone Number: +86 13995777482
    • Hunan
      • Changde, Hunan, China
        • Recruiting
        • The First People's Hospital of Changde City
        • Contact:
          • Tao Wu
          • Phone Number: +86 15873644000
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Quchang Ouyang
          • Phone Number: +86 13973135318
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Jun Huang
          • Phone Number: +86 18229944886
      • Yongzhou, Hunan, China
        • Recruiting
        • The Central Hospital of Yongzhou
        • Contact:
          • Sijuan Ding
          • Phone Number: +86 13574624257
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Yuan Yuan
          • Phone Number: +86 13851588800
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
          • Yongmei Yin
          • Phone Number: +86 13951842727
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Li Xie
          • Phone Number: +86 13605169652
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
          • Yanhua Liu
          • Phone Number: +86 18952171926
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Zhengkui Sun
          • Phone Number: +86 13907000210
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Lihua Kang
          • Phone Number: +86 13504334518
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
          • Chunjiao Wu
          • Phone Number: +86 18643112151
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Man Li
          • Phone Number: +86 17709873580
      • Jinzhou, Liaoning, China
        • Not yet recruiting
        • The First Affiliated Hospital of Jinzhou Medical University
        • Contact:
          • Zhenhua Zhai
          • Phone Number: +86 18641621266
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Yuee Teng
          • Phone Number: +86 13591639797
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
          • Tao Sun
          • Phone Number: +86 18900917877
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:
          • Jin Yang
          • Phone Number: +86 18991232383
    • Shan'Xi
      • Baoji, Shan'Xi, China
        • Recruiting
        • Baoji Central Hospital
        • Contact:
          • Youhuai Li
          • Phone Number: +86 13008470981
    • Shandong
      • Binzhou, Shandong, China
        • Not yet recruiting
        • Binzhou Medical University Hospital
        • Contact:
          • Fangling Ning
          • Phone Number: +86 15254311599
      • Jinan, Shandong, China
        • Recruiting
        • Shandong First Medical University and Shandong Academy of Medical Sciences
        • Contact:
          • Yongsheng Wang
          • Phone Number: +86 13505409989
      • Linyi, Shandong, China
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Jingfen Wang
          • Phone Number: +86 ‭15963973026‬
      • Linyi, Shandong, China
        • Recruiting
        • Linyi People'S Hostipal
        • Contact:
          • Yongli Gao
          • Phone Number: +86 ‭18669925810‬
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Wenfeng Li
          • Phone Number: +86 13589381517
      • Weifang, Shandong, China
        • Recruiting
        • Weifang People's Hospital
        • Contact:
          • Wenhui Wang
          • Phone Number: +86 13805368857
      • Weihai, Shandong, China
        • Recruiting
        • Weihai Municipal Hospital
        • Contact:
          • Hongyan Xu
          • Phone Number: +86 13021659685
        • Contact:
          • Chuxin Qin
          • Phone Number: +86 18863165616
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Jinsong Lu
          • Phone Number: +86 18018850676
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai General Hospital
        • Contact:
          • Qi Li
          • Phone Number: +86 13818207333
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Hui Li
          • Phone Number: +86 18908178707
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Yehui Shi
          • Phone Number: +86 13602088477
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Yabing Zheng
          • Phone Number: +86 13858065353
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Xuli Meng
          • Phone Number: +86 13757128803
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
          • Weizhu Wu
          • Phone Number: +86 13957402451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
SIM0270 to be taken orally as a capsule in combination with Everolimus.
Drug: SIM0270
Experimental
Drug: Everolimus (Afinitor®)
Experimental and Active comparator
Active Comparator: Control group

Investigator'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.
Drug: Everolimus (Afinitor®)
Experimental and Active comparator
Drug: Exemestane tablets
Active Comparator
Drug: Fulvestrant injection
Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1
Time Frame: 2 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS) , as assessed by investigator according to RECIST1.1
Time Frame: 2 year
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
Overall Survival (OS)
Time Frame: 3 year
OS is the time from the date of randomization to death from any cause.
3 year
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 3 year
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
3 year
Blood concentrations
Time Frame: At five specified time points of the first 6 cycles (each cycle is 28 days)
Blood concentrations of SIM0270 and everolimus
At five specified time points of the first 6 cycles (each cycle is 28 days)
Objective Response Rate (ORR) by investigator
Time Frame: 2 year
The objective response rate is defined as the percentage of subjects with a complete response or partial response.
2 year
Objective Response Rate (DOR) by investigator
Time Frame: 2 year
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.
2 year
ORR by BIRC
Time Frame: 2 year
The objective response rate is defined as the percentage of subjects with a complete response or partial response.
2 year
DOR by BIRC
Time Frame: 2 year
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.
2 year
Clinical benefit rate(CBR) by investigator
Time Frame: 2 year
The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks.
2 year
CBR by BIRC
Time Frame: 2 year
The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks.
2 year
Time To Progression (TTP) by investigator
Time Frame: 2 year
TTP is defined as the time from randomization until the date of first documented progression.
2 year
Time To Progression (TTP) by BIRC
Time Frame: 2 year
TTP is defined as the time from randomization until the date of first documented progression.
2 year
Change from baseline in EQ-5D-5L scores
Time Frame: 2 year
Change from baseline in EQ-5D-5L scores
2 year
Change from baseline in FACT-B scores
Time Frame: 2 year
Change from baseline in FACT-B scores
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

Nanjing Zaiming Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM0270-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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