A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Biostar Pharma, Inc.
You may qualify if…
- ✓ 1. Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH).
- ✓ 2. Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) .
- ✓ 3. Male or female aged ≥18 years.
- ✓ 4. ECOG PS 0 or 1.
- ✓ 5. Have a life expectancy of at least 3 months.
- ✓ 6. Have adequate baseline hematologic parameters.
- ✓ 7. Have adequate hepatic and renal function.
- ✓ 8. ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.
You may not qualify if…
- ✕ 1. Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology.
- ✕ 2. Any intracranial lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).
- ✕ 3. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy.
- ✕ 4. Had evidence of intracranial hemorrhage within 3 months before study treatment.
- ✕ 5. Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment.
- ✕ 6. Undergone major surgical procedures within 4 weeks or not fully recovered from surgery before study treatment.
- ✕ 7. Patients who have received anti-tumor therapies less than 2 weeks before the first dose of investigational product, including endocrine therapy, chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy or antibody-drug conjugate therapy.
- ✕ 8. Persistent toxicities caused by previous antitumor therapy (excluding alopecia), not yet improved to CTCAE v5.0 grade ≤ 1 or baseline.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06764940 · last updated 2026-08-21