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Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer

Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial

NCT07180160•Wenjin Yin

View on ClinicalTrials.gov

Summary

This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female, age≥18 years old
•Expected survival ≥12 weeks
•ECOG 0-1
•Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery
•ER and/or PR positive, HER2 negative
•At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
•Previously treated with ≤2 lines chemotherapy for advanced disease; previously treated with ≤2 CDK4/6 inhibitors
•Adequate organ function

Exclusion Criteria

•During pregnancy and lactation
•Patients with central nervous system metastasis

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

Key Dates

Start Date

September 25, 2025

Primary Completion Date

September 1, 2027

Completion Date

March 1, 2028

Last Updated

November 18, 2025

Enrollment

123

ESTIMATED participants

Conditions

Advanced Breast Cancer

Interventions

QL1706

DRUG

CDK4/6 inhibitor

DRUG

Fulvestrant

DRUG

Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569 yinwenjin@renji.com

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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: November 18, 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

Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

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