Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
Recruiting
Phase 2Interventional Study
Advanced Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
123 (estimated)
Sponsor
Wenjin Yin · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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…
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
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