Utidelone + Capecitabine for Breast Cancer with Brain Metastases

Overseen By Rongguo Qiu

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

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 5}

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

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]

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

Capecitabine for 5-fluorouracil-resistant brain metastases from breast cancer. [2019]

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]