Loading clinical trials...

RECRUITINGPHASE3

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

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

NCT06680921•Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (60)

The First Affiliated Hispital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hispital of Anhui Medical University

Hefei, Anhui, China

Maanshan People's Hospital

Maanshan, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Medical Center of PLA Ggeneral Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Key Dates

Start Date

November 14, 2024

Primary Completion Date

August 31, 2028

Completion Date

August 31, 2028

Last Updated

September 22, 2025

Enrollment

460

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Breast Cancer

Interventions

SIM0270

DRUG

Everolimus (Afinitor®)

DRUG

Exemestane tablets

DRUG

Fulvestrant injection

DRUG

Contacts

JING WANG

CONTACT

18624010252 wangjing16f919@zaiming.com

A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

NCT02514681

HER2-positive Locally Advanced or Metastatic Breast Cancer

View study

COMPLETED

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

NCT03027245

Locally Advanced or Metastatic Breast Cancer

View study

TERMINATEDPHASE1

Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions