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Anti-tumor antibiotic

Group of albumin-bound paclitaxel combined with apatinib for Breast cancer

Phase 2
Recruiting
Led By Yan Yang, M.D.,Ph.D
Research Sponsored by First Affiliated Hospital Bengbu Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Breast cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Adverse Event (AE)
Clinical Benefit Rate (CBR)
Overall Survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group of albumin-bound paclitaxel combined with bevacizumabExperimental Treatment2 Interventions
Albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks).
Group II: Group of albumin-bound paclitaxel combined with apatinibExperimental Treatment2 Interventions
Albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks).
Group III: Group of albumin-bound paclitaxelActive Control1 Intervention
Albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apatinib Mesylate
2016
Completed Phase 2
~240
Bevacizumab
2013
Completed Phase 4
~5540
Albumin-Bound Paclitaxel
2020
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

First Affiliated Hospital Bengbu Medical CollegeLead Sponsor
57 Previous Clinical Trials
138,228 Total Patients Enrolled
Yan Yang, M.D.,Ph.DPrincipal InvestigatorFirst Affiliated Hospital of Bengbu Medical College
1 Previous Clinical Trials
100 Total Patients Enrolled
~4 spots leftby Jan 2025