Utidelone + Capecitabine for Breast Cancer with Brain Metastases

Recruiting at 17 trial locations

Overseen By Simon Guan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biostar Pharma, Inc.

Must not be taking: Antitumor therapies

Disqualifiers: Leptomeningeal metastasis, Uncontrolled seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 5}

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

Life expectancy of at least 3 months

Adequate baseline hematologic parameters

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

My cancer has spread to the lining of my brain and spinal cord.

I have not fully recovered from a recent major surgery.

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive utidelone alone or in combination with capecitabine to evaluate intracranial and systemic efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Utidelone

Trial Overview

The study is testing the effectiveness and safety of a drug called Utidelone, both alone and in combination with another drug named Capecitabine, specifically for treating breast cancer that has spread to the brain.

How Is the Trial Designed?

Group I: (stage 2) combination group Experimental Treatment 1 Intervention

Group II: (stage 1) monotherapy group Experimental Treatment 1 Intervention

Group III: (stage 1) combination group B Experimental Treatment 1 Intervention

Group IV: (stage 1) combination group A Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biostar Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

150+

Published Research Related to This Trial

In a phase III trial involving 405 heavily-pretreated patients with metastatic breast cancer, the combination of utidelone and capecitabine significantly improved overall survival (OS) to a median of 19.8 months compared to 16.0 months for capecitabine alone, indicating a promising new treatment option.

The combination therapy also maintained superior progression-free survival (PFS) and overall response rate (ORR) compared to monotherapy, with no new safety concerns or late-emerging toxicities reported, suggesting it is a safe and effective regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial. Xu, B., Sun, T., Zhang, Q., et al.[2022]

In a study of 103 metastatic breast cancer patients, utidelone plus capecitabine showed significantly better progression-free survival (PFS) and overall survival (OS) in advanced first-line therapy compared to second-line treatments, with a median PFS of 11.70 months versus 5.60 months (P = 0.0077).

Utidelone plus capecitabine also outperformed vinorelbine plus cisplatin in advanced first-line therapy, achieving a median PFS of 11.70 months compared to 6.12 months, while maintaining a favorable safety profile with no treatment-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study. Bi, P., Wang, X., Liu, R., et al.[2023]

In a study of 95 women aged 55 and older with advanced breast cancer, oral capecitabine showed a higher overall response rate of 30% compared to 16% for the intravenous CMF regimen, indicating its effectiveness as a first-line treatment.

Capecitabine was generally well tolerated, with fewer instances of alopecia and myelosuppression compared to CMF, although it did lead to more cases of diarrhea and hand-foot syndrome, which were manageable with dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Oshaughnessy, JA., Blum, J., Moiseyenko, V., et al.[2022]

In a phase II study involving patients with metastatic breast cancer resistant to standard treatments, utidelone showed a promising objective response rate of 42.4% when combined with capecitabine, and a median progression-free survival of 7.9 months.

Utidelone demonstrated a favorable safety profile with manageable side effects, including mild peripheral neuropathy and fatigue, and significantly lower toxicity compared to other treatments, making it a potential new option for overcoming drug resistance in metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of utidelone as monotherapy or in combination with capecitabine in heavily pretreated metastatic breast cancer patients. Zhang, P., Tong, Z., Tian, F., et al.[2022]

In a phase 3 trial involving 405 patients with metastatic breast cancer, the combination of utidelone and capecitabine significantly improved progression-free survival (8.44 months) compared to capecitabine alone (4.27 months), indicating greater efficacy of the combination therapy.

While the combination therapy was generally well-tolerated, it was associated with a higher incidence of peripheral neuropathy (22%) compared to capecitabine alone (<1%), suggesting that while effective, monitoring for this side effect is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial. Zhang, P., Sun, T., Zhang, Q., et al.[2022]

A patient with brain metastases from breast cancer showed a significant partial response to oral capecitabine after previous treatments failed, including whole brain irradiation and chemotherapy with 5-fluorouracil.

After 2 months of capecitabine treatment, the patient's tumor size decreased and their performance status improved, with continued benefits observed over an 11-month treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine for 5-fluorouracil-resistant brain metastases from breast cancer. Wang, ML., Yung, WK., Royce, ME., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12399820/

Efficacy and safety of utidelone in pretreated patients with ...

This was the first clinical trial to demonstrate the anti-tumor activity of UTD1 in breast cancer patients with brain metastases. The FDA has ...

2.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/article-abstract/2835818

Utidelone Plus Bevacizumab for ERBB2-Negative ...

These findings suggest that combination therapy with utidelone plus bevacizumab is a potentially viable treatment for patients with ERBB2-negative metastatic ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05357417

Utidelone Plus Bevacizumab for Advanced Breast Cancer ...

This study aims to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain ...

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ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2012

Utidelone in combination with etoposide and bevacizumab ...

Utidelone in combination with etoposide and bevacizumab has shown promising anti-tumor activity and manageable toxicity in HER2 negative breast cancer patients ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40569584/

The U-BOMB Phase 2 Nonrandomized Clinical Trial

The findings of this nonrandomized clinical trial suggest the potential of utidelone plus bevacizumab for the treatment of patients with ERBB2-negative MBC and ...