UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Trial Parameters
Brief Summary
This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 to 70 years * With histologically confirmed HER2 negative recurrent and metastatic breast cancer * have at least one measurable lesion in the central nervous system (the longest diameter ≥ 10mm) * ECOG score (PS) of 0-2 * According to screening brain MRI, patients with CNS must meet the following conditions: 1. untreated brain metastases of breast cancer; 2. do not need immediate local treatment; 3. brain metastases of breast cancer which was treated in the past: 1. There are no clinical manifestations that have progressed after the previous local treatment of the central nervous system and require immediate local treatment. 2. All records related to the treatment of the central nervous system must be provided. 3. All toxicities related to the previous anti-tumor treatment of patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must be restored to ≤ level