Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer

Summary

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.

Eligibility

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

Conditions3

Interventions3

Related trials

• Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer — Wenjin Yin
• An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy — Fudan University
• Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer — Fudan University
• CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer — RenJi Hospital
• A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy — Zhejiang Cancer Hospital
• A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer — Beta Pharma (Suzhou) Co., Ltd.
• A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer — Fudan University
• A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer — InventisBio Co., Ltd

Browse More Trials