Anlotinib Combination With Vinorelbine in the HER2- Advanced Breast Cancer

Who cannot join

• 1. Prior treatment with bevacizumab, anlotinib and other antiangiogenic agents;
• 2. Patients who had previously used Vinorelbine with an interval time of less than 6 months from the end of medication;
• 3. Interval of less than 3 weeks after radiotherapy or chemotherapy; The interval after endocrine therapy was less than 1 week;
• 4. Associated diseases/history;(1) Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis > 50ml per day); Or bleeding symptoms of significant clinical significance or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation and above, or suffering from vasculitis, etc.;(2) Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except those who had been cured after intravenous catheterization due to chemotherapy) and pulmonary embolism, etc.;(3) hypertension, which cannot be well controlled by antihypertensive drug therapy (systolic blood pressure \& GT; 140 mmHg or diastolic pressure \> 90 mmHg); During the first 6 months of randomization, myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac dysfunction, clinically significant ventricular arrhythmias or ventricular arrhythmias, and symptomatic congestive heart failure;(4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g., diabetes, pulmonary fibrosis and acute pneumonia);(5) Renal insufficiency: urine protein ≥ ++ indicated by routine urine examination, or confirmed 24-hour urine protein level ≥1.0g;(6) History of live attenuated vaccine vaccination within 28 days prior to initial study administration or expected live attenuated vaccine vaccination during study period;(7) human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ mL; Hepatitis C, defined as hcV-RNA higher than the lower limit of assay) or co-infection with hepatitis B and c;(8) Severe infection, including but not limited to bacteremia and severe pneumonia requiring hospitalization, occurred within 4 weeks before the first administration; Active CTCAE grade 5.0≥2 infection requiring systemic antibiotic treatment within 2 weeks prior to initial administration or unexplained fever during screening/prior to initial administration \> 38.5°C (according to the investigator's judgment, fever caused by tumor can be included in the group); Evidence of active tuberculosis infection within 1 year before administration;
• 5. Have been diagnosed with any other malignant tumor within 3 years prior to entering the study;
• 6. Thyroid dysfunction;