Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients

Inclusion Criteria：

• Voluntarily sign an informed consent form;
• Females aged 18 years or older;
• ECOG physical performance status score of 0-2;
• Histologically confirmed HER2-negative metastatic breast cancer patients, and patientswith locally recurrent disease who cannot undergo curative surgery or radiationtherapy;
• HR-positive/HER2-negative advanced breast cancer patients who have primary endocrineresistance or disease progression after first-line endocrine ± targeted therapy;
• Triple-negative advanced breast cancer patients with disease progression afterfirst-line chemotherapy ± immunotherapy;
• Blood routine examination meets the following conditions: ①absolute neutrophil count (ANC) ≥1.5×10^9/L, ② platelets ≥100×10^9/L, ③ hemoglobin ≥90 g/L, ④ white blood cellcount ≥3.0×10^9/L;
• The liver function meets the following criteria: ① serum total bilirubin ≤ 1.5 × ULN,and if there is liver metastasis, it should be ≤ 3 × ULN; ② AST or ALT ≤ 3 × ULN, andif there is liver metastasis, it should be ≤ 5 × ULN;
• The renal function meets the following criteria: serum creatinine ≤ 1.5 × ULN orcreatinine clearance ≥ 50 mL/min (calculated according to the Cockroft-Gault formula);
• Female patients who meet the following criteria can participate in this study: ①Patients are not capable of reproduction; ② Patients have reproductive capacity, andhave a negative result on the pregnancy test within 7 days before the firstadministration of the investigational drug, are not in the lactation period, andcontinuously adopt effective contraceptive measures before entering the study andduring the entire study period and within 6 months after the last administration ofthe investigational drug.

Exclusion Criteria:

• Patients who have previously received treatment with vinorelbine and/or anlotinib;
• Patients with active or untreated brain metastasis;
• Patients who have had or currently have other malignancies within 5 years, except forcured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladdertumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invadesbasement membrane)];
• Patients who have undergone major surgery (including thoracotomy biopsy) or suffered asignificant trauma (such as bone fracture) within 4 weeks before randomization, haveunhealed wounds or fractures at the time of screening, or are expected to undergomajor surgery during the study period;
• Patients with a history of myocardial infarction within the past 6 months; history ofcongestive heart failure with New York Heart Association (NYHA) classification ≥ II,or severe arrhythmia (excluding atrial fibrillation and paroxysmal supraventriculartachycardia) that cannot be controlled by medication;
• Patients with known allergies to the drugs and their excipients involved in thistrial;
• Patients with a known history of hypersensitivity reactions to any investigationaldrugs;
• Patients who are simultaneously participating in other trials;
• Patients who cannot evaluate the efficacy of the treatment plan with existingtechnology;
• Patients judged unsuitable for participation by other investigators.