Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
Not Applicable
Not yet recruiting
- Conditions
- Advanced Breast Cancer
- Interventions
- Registration Number
- NCT07180160
- Lead Sponsor
- Wenjin Yin
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 123
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QL1706 QL1706 QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole QL1706 CDK4/6 inhibitor QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole QL1706 Fulvestrant QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole control CDK4/6 inhibitor CDK4/6 inhibitor + fulvestrant/letrozole control Fulvestrant CDK4/6 inhibitor + fulvestrant/letrozole
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 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) PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Adverse events From the date of starting study treatment to the end of the treatment (up to approximately 1 year) Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
🇨🇳Shanghai, China
Renji Hospital, School of Medicine, Shanghai Jiaotong University🇨🇳Shanghai, China