NCT05192798

Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC

A Prospective, Randomized, Open Label Clinical Study Evaluating Efficacy and Safety of Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: The First Affiliated Hospital of Bengbu Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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), 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.

Detailed description

Triple-negative breast cancer (TNBC) is a special type of breast cancer (BC), which cannot benefit from endocrine therapy and anti-human epidermal growth factor receptor-2 (HER-2) therapy due to lack of corresponding targets. Thus, it confers a hot spot and difficulty in clinical and basic research of BC. At present, the clinical treatment of TNBC is mainly relayed on chemotherapy based on anthracycline and taxane drugs with an unsatisfactory therapeutic effects and outcomes of the patients. Although data have suggested that antiangiogenic agents may have some benefit to TNBC patients, there seems to be a lack of clinical trials evaluating efficacy and safety of albumin paclitaxel combined with antiangiogenic agents in first-line treatment of relapsed or metastatic TNBC. 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 reduced, among which the lowest allowable dosage of apatinib and bevacizumab can be reduced to 250mg and 5mg/kg, respectively. The dosage of albumin-bound paclitaxel can be adjusted appropriately according to the toxic reaction of the patients. The lowest allowable dosage of albumin-bound paclitaxel can be reduced to 180mg/m2, specifically. 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. For statistical description, Kaplan-Meier method is used to plot the progression-free survival curve and estimate the median progression-free survival and its 95% confidence interval. The secondary analysis is to plot the overall survival curve using Kaplan-Meier method and estimate its 95% confidence interval. Log-rank test is used to analyze the overall survival of the main stratified factors. Objective response rate, disease control rate and 95% confidence interval are also calculated. The safety analyses will be mainly descriptive statistical analyses, listing the incidence, severity, association, risk, and outcome of adverse events that will occur in this study.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Albumin-Bound Paclitaxel	Albumin-bound paclitaxel is one of the standard first-line regimens for relapsed or metastatic triple-negative breast cancer.
DRUG	Apatinib Mesylate	Apatinib mesylate is an orally administered small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI).
DRUG	Bevacizumab	Bevacizumab is a humanized anti-VEGF monoclonal antibody once approved by FDA for treatment of metastatic breast cancer in combination with chemotherapy.

Timeline

• Start date: 2022-01-14
• Primary completion: 2025-09-10
• Completion: 2025-12-01
• First posted: 2022-01-14
• Last updated: 2025-02-27

Locations

1 site across 1 country: China