Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Sponsor
Henan Cancer Hospital
Study ID
NCT05357417
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 2, 2022
Start date
Apr 29, 2022
Status verified
Apr 2022
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 1
    HER2-negative advanced breast cancer with brain metastases who have received at least one prior anthracycline and one prior taxane
  • Experimental: cohort 2
    HER2-positive advanced breast cancer with brain metastases who have failed trastuzumab and pyrotinib

Primary Outcome Measure

CNS-ORR according to the RECIST 1.1. [ Time Frame: up to 2 years ]

Central Contacts

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