Phase II Utidelone for HER2-negative Breast Cancer with Brain Metastases

This study is testing Utidelone, alone or combined with capecitabine, for HER2-negative breast cancer that has spread to the brain (brain metastases). Researchers want to see how well these treatments shrink tumors in the brain and elsewhere in the body, and if they are safe. You could be eligible if you have HER2-negative metastatic breast cancer with at least one measurable brain tumor. The main goal is to measure how many patients have their brain tumors shrink. This study plans to enroll 120 participants, but its current status is unclear.

Study design
This is a multicenter, two-stage clinical trial that will enroll 120 participants. It is testing different ways of giving Utidelone, either alone or with capecitabine.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 12 months, which suggests follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06764940

A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
Biostar Pharma, Inc.
~120 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:UtideloneUtidelone in combination with capecitabine

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.
Measured over 12 months
HER2-negative Breast Cancer Patients With Brain Metastases
12 sites across 8 states
California3
Texas3
Colorado1
Georgia1
Illinois1
Maryland1
Nevada1
New York1

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  • Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.12 months