A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer

Exclusion Criteria

• •1. Known central nervous system (CNS) disease.
• •2. Uncontrollable moderate to large amounts of pleural effusion requiring repeated drainage, peritoneal effusion, or pericardial effusion.
• •3. Any subject with known or suspected autoimmune disease other than: hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy only; Subjects with stable type I diabetes in whom glycemia was controlled.
• •4. Within 6 months prior to randomization, the following conditions occurred: myocardial infarction, severe / unstable angina, cardiac insufficiency of NYHA class 2 and above, clinically significant supraventricular or ventricular arrhythmia requiring intervention, and symptomatic congestive heart failure.
• •5. Previous or current history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic interstitial pneumonia, or evidence of active pneumonia on chest CT screening; Patients with a history of radiation pneumonitis (fibrosis) in the irradiated field were excluded.
• •6. History of live attenuated influenza vaccination within 28 days before first dose of study medication or anticipated during the study.
• •7. Human immunodeficiency virus (HIV) infection or known to have acquired immune deficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or coinfection with hepatitis B and C.
• •8. Presence of severe infection including, but not limited to, bacteremia requiring hospitalization, severe pneumonia within 4 weeks prior to first dose; With evidence of active tuberculosis infection within 1 year before drug administration.
• •9. Had a diagnosis of any other malignancy within 5 years before study entry, with the exception of adequately treated basal cell carcinoma or squamous cell skin carcinoma, or carcinoma in situ of the cervix.
• •10. Major surgery within 28 days before randomization (tissue biopsy required for diagnosis and placement of a central venous catheter operation \[PICC\] via peripheral venipuncture were permitted).
• •11. Patients who had previously received or were ready to undergo allogeneic bone marrow transplantation or solid organ transplantation.