Utidelone + Capecitabine for Breast Cancer with Brain Metastases

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Biostar Pharma, Inc.

Must not be taking: Antitumor therapies

Disqualifiers: Leptomeningeal metastasis, Uncontrolled seizures, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine. The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.

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.

What data supports the effectiveness of the drug Utidelone combined with Capecitabine for treating breast cancer with brain metastases?

Research shows that Utidelone combined with Capecitabine significantly improved outcomes in patients with metastatic breast cancer, including those who had not responded to other treatments. Additionally, Capecitabine alone has been effective in treating brain metastases from breast cancer, suggesting the combination could be beneficial.

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Is the combination of Utidelone and Capecitabine safe for humans?

Studies have shown that Utidelone combined with Capecitabine has been evaluated for safety in patients with metastatic breast cancer, indicating it is generally safe for human use in this context.

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How is the drug Utidelone + Capecitabine different from other treatments for breast cancer with brain metastases?

Utidelone, a genetically engineered epothilone analogue, combined with capecitabine, offers a novel approach for treating breast cancer with brain metastases, especially in patients who have become resistant to other treatments like anthracyclines and taxanes. This combination has shown improved progression-free survival and overall response rates compared to capecitabine alone, making it a promising option for heavily pretreated patients.

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Eligibility Criteria

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

I am 18 years old or older.

Adequate baseline hematologic parameters

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

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

FOMAT Medical Research (Network) Oxnard, CA

Who Is Running the Clinical Trial?

Biostar Pharma, Inc. Lead Sponsor

References

1. England 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. [2022] Primary analysis of the phase III trial BG01-1323L demonstrated that utidelone plus capecitabine significantly improved progression-free survival (PFS) and overall response rate (ORR) versus capecitabine alone in heavily-pretreated patients with metastatic breast cancer (MBC). Here, we report the final overall survival (OS) analysis and updates of other endpoints.

2. England 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. [2022] Utidelone, a genetically engineered epothilone analogue, has shown promise as a potential treatment for breast cancer in phase 1 and 2 trials. The aim of this phase 3 trial was to compare the efficacy and safety of utidelone plus capecitabine versus capecitabine alone in patients with metastatic breast cancer.

3. United States 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. [2023] The purpose of this study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer.

4. England pubmed.ncbi.nlm.nih.gov

Phase II trial of utidelone as monotherapy or in combination with capecitabine in heavily pretreated metastatic breast cancer patients. [2022] The treatment of metastatic breast cancer (MBC) remains a great clinical challenge as drug resistance frequently develops. Alternative agents that can overcome drug resistance would offer new therapeutic options. The primary aim of this phase II study was to evaluate the efficacy and safety of utidelone as a monotherapy or in combination with capecitabine in metastatic breast cancer patients previously treated with and resistant to anthracyclines and taxanes.

5. United States pubmed.ncbi.nlm.nih.gov

Capecitabine for 5-fluorouracil-resistant brain metastases from breast cancer. [2019] We report a case in which brain metastases originating from breast cancer responded to treatment with oral capecitabine. The metastases had progressed and Karnofsky performance status deteriorated despite whole brain irradiation, hormonal treatment, and systemic chemotherapy that included 5-fluorouracil (5-FU). In contrast, 2 months of treatment with oral capecitabine produced a partial response, documented by lesion size on magnetic resonance imaging and an improvement in performance status; both measures continued to improve during 11 months of capecitabine treatment.

6. England 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. [2022] Oral capecitabine was evaluated in terms of overall response rate, safety, and tolerability as first-line therapy in women aged > or = 55 years with advanced/metastatic breast cancer.