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

NCT06680921 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SIM0270

Experimental

DRUG

Everolimus (Afinitor®)

Experimental and Active comparator

DRUG

Exemestane tablets

Active Comparator

DRUG

Fulvestrant injection

Active Comparator

Sponsors & Collaborators

  • Nanjing Zaiming Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680921 on ClinicalTrials.gov