NCT05398861

Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer

A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.

Detailed description

Patients included were patients with ≥ 2 lines of HER2-negative advanced breast cancer who had previously failed taxanes and/or anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who had progressed after at least 1 line of prior endocrine therapy. This study used a Simon two-stage design. 71 subjects will be enrolled using the optimal design.

Conditions

• HER-2 Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	utidelone injection	Utidelone： 30 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle Bevacizumab：10mg/kg (IV), on day 1 of each 21 days.
DRUG	Bevacizumab	Bevacizumab: 10mg/kg, administered on day 1 of each cycle, with a treatment cycle lasting 21 days;

Timeline

• Start date: 2022-08-19
• Primary completion: 2026-12-30
• Completion: 2027-05-30
• First posted: 2022-06-01
• Last updated: 2026-04-16

Locations

1 site across 1 country: China