This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR, complete response (CR)+ partial response (PR) + stable disease (SD, \> 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.
Female patients aged ≥18 years and ≤80 years;
Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;
Presence of at least one measurable lesion according to RECIST 1.1;
Expected survival ≥3 months;
Patients who are pregnant or breast-feeding;
Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);
Known hypersensitivity reaction to any of the components of the treatment;
Peripheral neuropathy ≥ grade 2, whatever the cause;
Parallel
Albumin-Bound Paclitaxel
DrugAlbumin-bound paclitaxel is one of the standard first-line regimens for relapsed or metastatic triple-negative breast cancer.
Apatinib Mesylate
DrugApatinib mesylate is an orally administered small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI).
Bevacizumab
DrugBevacizumab is a humanized anti-VEGF monoclonal antibody once approved by FDA for treatment of metastatic breast cancer in combination with chemotherapy.
Progression-free Survival (PFS)
PFS is defined as the time from randomization until objective tumor progression or death.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients who have a complete, partial response or stable disease for more than 6 months to therapy.
objective response rate (ORR)
ORR is defined as the proportion of patients who have a partial or complete response to therapy.
Overall Survival (OS)
OS is defined as the time from randomization to the time of death from any cause.
Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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