Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
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), CBR (CR+PR+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.