Iparomlimab and Tuvonralimab (QL1706) with CDK4/6 inhibitor and fulvestrant for HR-positive, HER2-negative advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.