Breast Cancer – BG01-2402
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.
Inclusion Criteria:
- Have histologically confirmed HER2-negative metastatic breast cancer
- Male or female aged ≥18 years
- Have a life expectancy of at least 3 months
- Patients must be able to follow the study visit schedule and must be able of sign and give informed consent in accordance with institutional review board
- Other criteria may apply
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