NCT05357417

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases: A Multicenter, Single Arm, Open Label, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases, and thus provides a new systemic treatment strategy for those patients.

Detailed description

This is a multicenter,open label, phase 2 trial to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases. Patients with HER2-negative advanced breast cancer who have received at least one prior anthracycline and one prior taxane or HER2-positive advanced breast cancer who have failed trastuzumab and pyrotinib, and with at least one measurable CNS lesion are eligible for the study. This study includes 2 cohorts, and the Simon two-stage design are applied, respectively. A total of 48 patients with HER2-negative advanced breast cancer are included in cohort 1, and 52 patients with HER-2 positive patients are enrolled in cohort 2. Patients in both cohorts receive bevacizumab, 15mg/kg, day 1, and utidelone, 30mg/m2 (±10%), day 1-5 every 3-week cycle until disease progression or unmanageable toxicity. The primary endpoint is CNS-ORR according to the RECIST 1.1. The secondary endpoints include CNS-ORR according to RANO criteria, CNS-PFS assessed by investigator, extracranial ORR, extracranial PFS, OS, time to WBRT, quality of life and safety profile according to NCI-CTCAE 5.0.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	utidelone	30mg/m2 (±10%), day 1-5 every 3-week cycle
DRUG	Bevacizumab	15mg/kg, day 1

Timeline

• Start date: 2022-04-29
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-05-02
• Last updated: 2022-09-16

Locations

1 site across 1 country: China