AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer

Exclusion Criteria

• •Pregnant, lactating or planning to become pregnant during the study period.
• •Allergic to any of the drugs in the study.
• •Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or anti-vascular targeted therapy.
• •Central nervous system (CNS) metastases.
• •Concomitant disease/medical history:
• •1. Patients with any known or suspected autoimmune diseases.
• •2. Hypertension.
• •3. Peripheral neuropathy ≥ Grade 2.
• •4. Persons with a history of unstable angina or arrhythmia.
• •5. Active or uncontrolled serious infection .
• •6. History of immunodeficiency.
• •7. Active hepatitis B or C.
• •8. interstitial lung disease or non-infectious pneumonia.
• •9. Active tuberculosis.
• •10. Urine protein is ≥++, and 24-hour urine protein quantitative is \>1.0g.
• •11. Suffered from other malignant tumors within 5 years before enrollment.
• •12. Unreduced toxicity .
• •13. Multiple factors that affect oral medications.
• •14. Abnormal coagulation function.
• •15. Major surgical treatment, open biopsy or traumatic injury within 4 weeks.
• •16. Tumor has invaded the periphery of important blood vessels.
• •17. Patients who have seizures.
• •18. Bleeding constitution or medical history.
• •19. Arterial/venous thrombotic events before enrollment or within 6 months.
• •20. Live attenuated vaccine vaccination within 28 days before the study.
• •21. Uncontrollable pleural, abdominal or pericardial effusion.
• •22. Other uncontrollable systemic diseases.
• •Other serious physical or mental diseases or laboratory abnormalities.
• •Patients who the researcher thinks are not suitable for this research.
• •Participated in clinical trials of other anti-tumor drugs within four weeks.