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.
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
At a glance
Conditions
Where it's being run
12 sites across 8 statesWho to contact
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What this trial measures
- Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.12 months