Utidelone + Capecitabine for Breast Cancer with Brain Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining utidelone, a chemotherapy drug, with capecitabine for treating HER2-negative breast cancer that has spread to the brain. The researchers aim to determine if these medications can effectively manage tumors in both the brain and body while ensuring patient safety. Individuals with HER2-negative breast cancer that has metastasized to the brain, and who have untreated or progressing brain tumors visible on an MRI, may be suitable candidates for this trial. Participants will receive either utidelone alone or in combination with capecitabine to evaluate which treatment is more effective. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should not have received anti-tumor therapies within 4 weeks before the first dose of the investigational product. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that utidelone, whether used alone or with capecitabine, is generally well-tolerated. In past studies with patients who had advanced cancer, utidelone demonstrated promising results with manageable side effects. Some patients experienced nausea, tiredness, and low blood cell counts, but these were usually mild or moderate and could be treated.
When combined with capecitabine, studies found utidelone to be safe for patients with cancer that has spread to the brain. Common side effects included redness and swelling of the hands and feet, known as hand-foot syndrome, which were also manageable.
These findings suggest that both treatments are generally safe. Participants in this trial will be closely monitored for any side effects to ensure safety throughout the study.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for breast cancer with brain metastases, which typically involve a combination of surgery, radiation, and chemotherapy, Utidelone stands out due to its unique mechanism of action. Utidelone is a novel epothilone analog, which works by stabilizing microtubules, thus preventing cancer cell division and growth. Researchers are excited about Utidelone because it offers a new approach that might be more effective in penetrating the blood-brain barrier, a significant challenge in treating brain metastases. Additionally, when combined with Capecitabine, an oral chemotherapy drug, Utidelone could potentially enhance treatment efficacy while providing a more convenient administration route.
What evidence suggests that this trial's treatments could be effective for HER2-negative breast cancer with brain metastases?
This trial will evaluate the effectiveness of utidelone, both as a monotherapy and in combination with capecitabine, for treating breast cancer with brain metastases. Research has shown that using utidelone with capecitabine may help treat breast cancer that has spread to the brain. In one study, this combination helped patients live longer without their cancer worsening and improved their overall health. Another study found that utidelone alone also helped fight tumors in breast cancer patients with brain metastases. These findings suggest that utidelone, whether used alone or with capecitabine, could be effective in managing this challenging condition. Overall, this evidence offers hope for its potential effectiveness.12345
Are You a Good Fit for This Trial?
This trial is for HER2-negative breast cancer patients who have brain metastases. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have tried other treatments first.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive utidelone alone or in combination with capecitabine to evaluate intracranial and systemic efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Utidelone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biostar Pharma, Inc.
Lead Sponsor