A Study of SIM0270 Combined with Everolimus Vs. Treatment of Physician's Choice in Patients with ER+/HER2- Advanced Breast Cancer (SIMRISE)
- Conditions
- Locally Advanced or Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT06680921
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Fulvestrant injection 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. Control group Everolimus (Afinitor®) 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. Experimental group SIM0270 SIM0270 to be taken orally as a capsule in combination with Everolimus. Experimental group Everolimus (Afinitor®) SIM0270 to be taken orally as a capsule in combination with Everolimus. Control group Exemestane tablets 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.
- Primary Outcome Measures
Name Time Method Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1 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.
- Secondary Outcome Measures
Name Time Method Progression free survival(PFS) , as assessed by investigator according to RECIST1.1 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.
Overall Survival (OS) 3 year OS is the time from the date of randomization to death from any cause.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) 3 year Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Blood concentrations At five specified time points of the first 6 cycles (each cycle is 28 days) Blood concentrations of SIM0270 and everolimus
Objective Response Rate (ORR) by investigator 2 year The objective response rate is defined as the percentage of subjects with a complete response or partial response.
Objective Response Rate (DOR) by investigator 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.
ORR by BIRC 2 year The objective response rate is defined as the percentage of subjects with a complete response or partial response.
DOR by BIRC 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.
Clinical benefit rate(CBR) by investigator 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.
CBR by BIRC 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.
Time To Progression (TTP) by investigator 2 year TTP is defined as the time from randomization until the date of first documented progression.
Time To Progression (TTP) by BIRC 2 year TTP is defined as the time from randomization until the date of first documented progression.
Change from baseline in EQ-5D-5L scores 2 year Change from baseline in EQ-5D-5L scores
Change from baseline in FACT-B scores 2 year Change from baseline in FACT-B scores
Trial Locations
- Locations (2)
Harbin Medical University Cancer Hospital
🇨🇳Haerbin, Heilongjiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China