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

Studying new treatment for HER2-negative breast cancer with brain metastases.

Recruiting
18 years and older
All
Phase 2

This study checks how well a treatment, combining two medicines called utidelone and capecitabine, works for people with a type of breast cancer that has spread to the brain. These patients have a specific kind of cancer called HER2-negative, meaning it lacks a protein that usually helps cancer grow. The study has two stages to see if this new treatment can help both in the brain and overall in the body. People in the study will get utidelone alone or with capecitabine.

Patients must be adults (18+), have specific cancer characteristics, and be able to visit doctors regularly. They should not have certain other health problems, like uncontrolled seizures or recent surgeries.

  • Study duration depends on response and could involve multiple visits.
  • Participants will receive utidelone alone or with capecitabine.
  • Potential risks include side effects from the medicines.

Doctors will monitor patients to ensure safety and effectiveness. Women and men must use birth control during and after the study, and patients must agree to follow study rules and visit schedules. This study helps understand new treatment possibilities for this serious condition.

Study details
    HER2-negative Breast Cancer Patients With Brain Metastases

NCT06764940

Biostar Pharma, Inc.

17 October 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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