Iparomlimab and Tuvonralimab (QL1706) with CDK4/6 inhibitor and fulvestrant for 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
This trial will test whether adding Iparomlimab and Tuvonralimab (QL1706) to a CDK4/6 inhibitor and fulvestrant helps women with hormone receptor–positive, HER2–negative advanced breast cancer get better tumor control or live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 123 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy, Iparomlimab, Tuvonralimab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07180160 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled Phase 2 trial conducted at multiple centers that compares QL1706 combined with a CDK4/6 inhibitor and fulvestrant against standard therapy in patients with ER/PR-positive, HER2-negative recurrent or metastatic breast cancer. Eligible participants are adult women with measurable or bone-only disease, ECOG 0–1, adequate organ function, and limited prior exposure to chemotherapy and CDK4/6 inhibitors. The study will monitor tumor response, disease progression, and safety outcomes during treatment and follow-up. Treatment effects will be analyzed to determine whether the addition of QL1706 improves clinical outcomes without unacceptable toxicity.
Who should consider this trial
Good fit: Adult women with ER and/or PR positive, HER2 negative recurrent or metastatic breast cancer, ECOG 0–1, at least one measurable lesion or bone-only disease, previously treated with up to two lines of chemotherapy and up to two CDK4/6 inhibitors, and with adequate organ function are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have untreated central nervous system metastases, poor performance status, or who exceed prior treatment limits may be ineligible or less likely to benefit.
Why it matters
Potential benefit: If successful, this combination could improve tumor control and lengthen progression-free survival for patients with HR-positive, HER2-negative advanced breast cancer.
How similar studies have performed: Immune checkpoint approaches in hormone receptor–positive breast cancer remain experimental and have shown mixed early results, so combining QL1706 with endocrine and CDK4/6 therapy is a novel and unproven strategy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Wenjin Yin, M.D. — Renji Hospital,School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjin Yin, M.D.
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.