Clinical trial · Interventional
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
NCT07180160CI-TRIAL-00097448ITHRANrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDK4/6 inhibitor | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QL1706
- description
- QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole
- interventionNames
- Drug: QL1706
- Drug: CDK4/6 inhibitor
- Drug: Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- CDK4/6 inhibitor + fulvestrant/letrozole
- interventionNames
- Drug: CDK4/6 inhibitor
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.