him typing guides the treatment of advanced first-line triple-negative breast cancer

Conditions: Advanced Triple Negative Breast Cancer

Summary: to explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (him).


Eligibility criteria:
inclusion criteria: 1. more than 18 years old; 2. ecog ps score: 0\~1; 3. patients must have a life expectancy ≥ 3 months; 4. histopathologically confirmed recurrent metastatic triple-negative invasive breast cancer (her2-negative: ihc 0/1+ or ihc 2+ with negative ish; er-negative: ihc \<1%, pr-negative: ihc \<1%)； 5. at least one measurable lesion according to recist 1.1 criteria； 6. no prior systemic anti-tumor therapy during the recurrent or metastatic stage； 7. sufficient tissue samples for him subtyping analysis (at least 15 unstained slides from the most recent metastatic lesion biopsy are required; primary lesion samples from treatment-naive patients are acceptable, and re-biopsy samples from such patients are also acceptable)； 8. adequate organ function and marrow function; 9. willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up. exclusion criteria: 1. has leptomeningeal metastasis or cystic metastatic lesions confirmed by mri or lumbar puncture; 2. existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g.； 3. received systemic anti-tumor therapy within 14 days prior to enrollment; 4. imaging shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade critical vessels during the study period, leading to life-threatening hemorrhage； 5. uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/l, serum calcium \> 12 mg/dl, or albumin-corrected serum calcium \> uln); or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy； 6. prior treatment with immune checkpoint inhibitors other than pd-1/pd-l1 monoclonal antibodies (including but not limited to ctla-4 antibodies, etc.), or anti-angiogenic agents (including monoclonal antibodies and tkis)； 7. history of other malignancies within the past 5 years, having received any systemic anti-tumor therapy or local treatment (including surgery and radiotherapy) for malignancies, excluding cured in situ carcinomas, cervical carcinoma, basal cell carcinoma, squamous cell carcinoma, thyroid carcinoma, and other malignancies; 8. major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures (tissue biopsy for diagnostic purposes and peripherally inserted central catheter placement are allowed); 9. any known or suspected autoimmune disease, except for: hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; or stable type i diabetes with controlled blood glucose; 10. presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia, etc.); 11. history of live or attenuated live vaccination within 28 days prior to the first study dose or planned live or attenuated live vaccination during the study period; 12. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids); active hepatitis (hepatitis b, defined as hbv-dna ≥ 30 copies/ml; hepatitis c, defined as hcv-rna above the lower limit of detection of the assay method) or co-infection with hepatitis b and c; autoimmune hepatitis; 13. severe infections within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infections requiring systemic antibiotic treatment with ctcae ≥ grade 2 within 2 weeks prior to the first dose; or unexplained fever \> 38.5°c during screening or prior to the first dose (fever due to tumor-related causes, as judged by the investigator, is allowed); evidence of active tuberculosis infection within 1 year prior to dosing; 14. history of or planned allogeneic bone marrow transplantation or solid organ transplantation; 15. peripheral neuropathy ≥ grade 2; 16. severe cardiac disease or conditions； 17. subjects who have received systemic immunostimulant therapy (including but not limited to interferon or interleukin-2, including immunostimulants in clinical research stages) within 4 weeks prior to the first dose; 18. subjects who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, azathioprine, methotrexate, thalidomide, anti-tumor factor drugs) within 2 weeks prior to the first dose. this exclusion does not apply to intranasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/day prednisone or equivalent doses of other corticosteroids)； 19. known allergy to the investigational drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies; 20. female patients during the gestation or suckling period, of childbearing potential and pregnancy test-positive, or unwilling to use an effective method of contraception during the whole study; 21. a documented history of neurological or psychiatric disorders, including epilepsy or dementia, or a known history of substance abuse, alcoholism, or drug addiction. 22. any other conditions not appropriate for study enrolment in the opinion of the investigator.