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.

Who can Participate

Inclusion Criteria: 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). (According to the 2023 American Society of Clinical Oncology [ASCO]/ College of American Pathologists [CAP] guidelines). 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) and must have one of the following: A) Untreated brain metastases not needing immediate local therapy. B) Brain metastases progressing after prior local therapy. 3. Male or female aged more than or equal to 18 years. Exclusion Criteria: 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 12 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. Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.

Study ID

More information available at ClinicalTrials.gov: NCT06764940