Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC
Sponsor: The First Affiliated Hospital of Bengbu Medical University • ClinicalTrials.gov ID: NCT05192798
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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.
Interventions
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Albumin-Bound Paclitaxel
(Drug)
Albumin-bound paclitaxel is one of the standard first-line regimens for relapsed or metastatic triple-negative breast cancer.
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Apatinib Mesylate
(Drug)
Apatinib mesylate is an orally administered small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI).
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Bevacizumab
(Drug)
Bevacizumab is a humanized anti-VEGF monoclonal antibody once approved by FDA for treatment of metastatic breast cancer in combination with chemotherapy.
Eligibility criteria
Conditions
Locations
- Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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