The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer

Inclusion Criteria: * Aged 18 years or older female； * ECOG score 0-1; * Life expectancy is not less than 12 weeks; * Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer; * Premenopausal women have taken effective ovarian function suppression methods, such as drug suppression or ovariectomy; * At least one objectively measurable breast cancer lesions according to RECIST 1.1 ; * No more than one systemic chemotherapy for metastatic disease; * Disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy; * Normal function of main organs and bone marrow: Hemoglobin≥90g/L; Neutrophil count (ANC)≥1.5×109/L; Platelet count (PLT)≥80×109/L; Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤5×ULN if has liver metastasis); Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60mL/min (Cockcroft-Gault formula); * Sign the informed consent; Exclusion Criteria: * Have received prior fulvestrant or anti-angiogenic drug treatment, or known to be allergic to any excipients in the study; * Visceral crisis; * Uncontrolled or high-burden CNS metastases; * Unable to swallow; * Abnormal coagulation function; * Tumor has invaded important blood vessels and may cause fatal bleeding; * Pleural effusion or pericardial effusion that requiring repeated drainage; * Hypertension that cannot be well controlled by a single antihypertensive drug; * Unstable angina, myocardial infarction within 6 months, serious arrhythmias; * The history of immunodeficiency, including HIV or other obtained or congenital immunodeficiency diseases, or a history of organ transplantation; * Poorly controlled diabetes; * Abnormal urine protein, and the 24-hour quantification suggests urine protein ≥1.0g; * Bleeding constitution or medical history * Unhealed wounds, ulcers or fractures; * Have arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; * In other clinical trials of anti-tumor drugs simultaneously; * Other concomitant disease or disability that endangers safety according to the judgment of investigator;