Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL1706, CDK4/6 inhibitor, Fulvestrant.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug QL1706
QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4). - Drug CDK4/6 inhibitor
palbociclib OR ribociclib OR abemaciclib OR dalpiciclib - Drug Fulvestrant
SERD
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From the date of starting study treatment to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)]
Secondary outcome measures (1)
- Adverse events [Time frame: From the date of starting study treatment to the end of the treatment (up to approximately 1 year)]
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) 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai
Identifiers
NCT: NCT07180160 · LY2025-215-C