Breast cancer
Conditions
Interventions
Experimental group:Epalolitovorellizumab in combination with eribulin
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years, gender not restricted; 2.Histologically confirmed triple-negative breast cancer (TNBC): – HER2 negative: IHC 0/1+, or IHC 2+ with negative ISH; – ER negative: = 1 line of prior systemic therapy; 4.At least one measurable lesion according to the RECIST 1.1 criteria; 5.ECOG PS: 0-2; 6.Women of childbearing potential must undergo a serum pregnancy test within 7 days before the first dose, with a negative result. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use contraception from the time of signing the informed consent form until 24 weeks after the last dose of the study drug; 7.Adequate organ function within 14 days before enrolment, defined as: Haematology (no transfusion, growth factors or other corrective agents within 14 days): – ANC >= 1.5 × 10^9/L – Platelets >= 75 × 10^9/L – Hb >= 9 g/dL Biochemistry: – Serum creatinine = 50 mL/min – Total bilirubin <=1.5 × ULN (<=3 × ULN for Gilbert’s syndrome) – ALT and AST <=3 × ULN (<=5 × ULN if liver metastases) Coagulation: – APTT and INR <=1.5 × ULN (no anticoagulant or other corrective agents within 14 days, except stable anticoagulation for underlying medical condition); 8.Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Known other malignant tumors requiring treatment or progressing within the past 5 years; 2.Participation in another interventional clinical trial or use of any investigational drug or device within 28 days before informed consent; 3.Systemic chemotherapy or biological therapy within 3 weeks, or radiotherapy or small-molecule targeted therapy within 2 weeks before informed consent; 4.Suffering from severe cardiovascular diseases, such as heart failure with New York Heart Association (NYHA) classification of Grade 2 or higher, myocardial infarction within 3 months before screening, poorly controlled arrhythmia or unstable angina pectoris, and severe arterial/venous thromboembolic events (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism, etc.) within 3 months before screening; 5.Untreated CNS or leptomeningeal metastases, or treated but still symptomatic CNS/leptomeningeal disease. Asymptomatic, untreated CNS or leptomeningeal metastases, or treated lesions that have been stable and asymptomatic are permitted; 6.Previous receipt of any other antibodies/drugs acting on T-cell costimulation or checkpoint pathways (including but not limited to PD-1, PD-L1, PD-L2, CTLA-4, OX40, C137 inhibitors, etc.); 7.Receipt of live attenuated vaccines within 30 days before the first dose or planned receipt during the study period; 8.Having active infections requiring systemic treatment; 9.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years; 10.Systemic corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days before first dose; 11.Subjects who, in the investigator's judgment, have other factors that may lead to forced termination of the study, such as non-compliance with the protocol, other severe diseases (including mental illness) requiring combined treatment, severe laboratory test abnormalities, or family, social and other factors that may affect the subject's safety or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactLiu Jiannan
Yantai Yuhuangding Hospital
Outcome results
None listed