A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer
This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.
• Signed Informed Consent Form;
• Women aged 18-70 years;
• The number of treatment lines for patients ≥ 2 lines；
• Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:
• Patients with HER2-negative breast cancer who have failed previous treatment with taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who have progressed after at least one line of previous endocrine drug therapy;
• Eastern Cooperative Oncology Group (ECOG) score \[0-2\] points，Life expectancy of not less than 3 months；
• At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1)；
• Adequate hematological, hepatic and renal function；
• Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior anticancer therapy；
⁃ Women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after administration of the study drug; Subjects must be non-lactating and have a negative serum or urine pregnancy test within 7 days prior to study enrollment