Phase II Study of Utidelone and Capecitabine for HER2-negative Breast Cancer with Brain Metastases

Inclusion Criteria

• Diagnosed with HER2-negative metastatic breast cancer, confirmed by specific lab tests.
• Have at least one measurable brain tumor, as shown by a brain MRI scan.
• Be 18 years or older.
• Be in good overall health, with a performance status score of 0 or 1.
• Have a life expectancy of at least 3 months.
• Have adequate blood, liver, and kidney function.
• Have received no more than three previous chemotherapy treatments for advanced cancer.
• Women of childbearing potential must use effective birth control before, during, and after the study.
• Be able to attend study visits and provide informed consent.

Exclusion Criteria

• Have cancer that has spread to the brain's protective layers, confirmed by MRI or spinal fluid tests.
• Have brain tumors that need immediate treatment.
• Have uncontrolled seizures or worsening neurological symptoms due to brain tumors.
• Have had bleeding in the brain within the past year.
• Have had significant bleeding from the lungs or other bleeding issues recently.
• Have had major surgery within the past month and not fully recovered.
• Have received certain cancer treatments recently.
• Have ongoing side effects from previous cancer treatments.
• Have severe nerve damage.
• Have allergies to the study drugs.
• Have a specific enzyme deficiency affecting drug metabolism.
• Did not respond to previous capecitabine treatment.
• Are pregnant or breastfeeding.
• Have had other cancers in the past 5 years, except for certain skin, cervical, or thyroid cancers.
• Are participating in another clinical trial.
• Have active or uncontrolled infections like hepatitis B, syphilis, or HIV.
• Have severe or uncontrolled diseases.
• Have autoimmune diseases requiring steroid treatment.
• Cannot undergo MRI scans due to medical devices or other reasons.
• Have other severe health issues that make participation inappropriate.