Advanced Breast Cancer
Conditions
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.
Interventions
DRUGQL1706
QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4).
DRUGCDK4/6 inhibitor
palbociclib OR ribociclib OR abemaciclib OR dalpiciclib
DRUGFulvestrant
SERD
Sponsors
Wenjin Yin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Outcome results
None listed