This study is an open-label, prospective, phase 2, randomized controlled study to evaluate the efficacy and safety of apolitovorrelizumab (QL1706) in combination with platinum chemotherapy versus platinum chemotherapy in the treatment of advanced unresectable and or metastatic triple negative breast cancer previously treated with first-line or second-line systems. It is planned to enroll 78 subjects in this study. Subjects who meet the inclusion and exclusion criteria are divided into a random ratio of 1:1. The experimental group will receive QL1706 in combination with platinum chemotherapy selected by the investigator, and the control group will receive platinum chemotherapy selected by the investigator. A treatment cycle will be held every 3 weeks until disease progression or intolerable toxicity occurs. After subjects in the control group withdraw from the study, they are allowed to receive other treatments selected by the QL1706 co-investigators based on the subjects 'wishes. Efficacy assessments will be conducted every 6 weeks (42 days ±7 days) after treatment until disease progression, withdrawal of informed consent, death, or start of new antitumor therapy, whichever comes first.
Age ≥18 years, regardless of gender;
ECOG performance status: 0-1;
Locally advanced or metastatic triple negative breast cancer confirmed by histopathology that is not suitable for curative treatment and cannot be treated surgically (Defined as negative for HER2, ER and PR expression according to the latest ASCO/CAP guidelines);
Patients who have previously received first-line or second-line systemic treatment for locally advanced or metastatic breast cancer and have experienced recurrence within 12 months after the end of previous adjuvant therapy are counted as first-line systemic therapy;
Previous use of CTLA-4 monoclonal antibody or PD-1/PD-L1 and CTLA-4 bispecific antibodies (such as cardonilumab, KN046, etc.) or bifunctional combination antibodies (e.g., apolitto vorrelizumab);
relapse within 6 months after the end of previous (new) adjuvant immune checkpoint inhibitor therapy; or progression-free survival of locally advanced or metastatic breast cancer receiving immune checkpoint inhibitor therapy; 6 months;
relapse within 6 months after the end of previous (new) adjuvant platinum therapy; Or locally advanced or metastatic breast cancer receiving platinum therapy has a progression-free survival of <3 months (if the drug is discontinued due to non-tumor progression factors, but the duration of discontinuation is ≥3 months before randomization, you can participate in this study);
Those who have experienced immune-related toxicity that led to permanent drug discontinuation during previous anti-tumor immunotherapy, or have experienced immune-related adverse events (irAEs) of ≥ grade 3 or immune-related myocarditis of ≥ grade 2 and are assessed by the investigator as not suitable for treatment in this study. Grade 3 endocrine abnormalities with stable control of hormone replacement therapy can be enrolled after the investigator assessed that these irAEs will not affect the administration of study drugs and safety assessment;