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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4).
palbociclib OR ribociclib OR abemaciclib OR dalpiciclib
SERD
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
RECRUITINGProgression-Free Survival (PFS)
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.
Time frame: 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)
Adverse events
Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.
Time frame: From the date of starting study treatment to the end of the treatment (up to approximately 1 year)
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