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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
UTD1: 30mg/m2/day, once a day, continuously from day 1 to day 5, 21 days as a treatment cycle. Capecitabine: 2000mg / m2 / day, continuously from day 1 to day 14, orally twice a day, 21 days as a treatment cycle.
Quchang Ouyang
Changsha, China
RECRUITINGCNS-Objective Response Rate (ORR)
The proportion of patients with complete remission (CR) and partial remission (PR) as the best efficacy evaluation in the total number of evaluable patients observed during the process from enrollment to the progression of all CNS target lesions assessed according to the RANOBM criteria.
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.
CNS clinical benefit rate (CNS-CBR)
The percentage of patients who achieved complete response (CR), partial response (PR) or disease stability (SD) as the best efficacy evaluation in the total number of evaluable patients observed from enrollment to all CNS target lesions assessed according to the RANOBM criteria.
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RANOBM standard up to 1 year.
CNS progression free survival (CNS-PFS)
The time from enrollment to the first imaging confirmed disease progression (PD) of all central nervous system target lesions (RANOBM criteria) or death due to any cause without progression recorded.
Time frame: From enrollment to the first imaging confirmed disease progression (PD) of all central nervous system target lesions (RANOBM criteria) or death due to any cause without progression recorded up to 1 year.
CNS objective response rate (CNS-ORR)
The proportion of patients with complete remission (CR) and partial remission (PR) as the best efficacy evaluation in the total number of evaluable patients observed during the process from enrollment to the progression of all CNS target lesions assessed according to the RECIST 1.1 criteria.
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RECIST 1.1 standard up to 1 year.
Objective response rate (ORR)
According to RECIST 1.1 criteria, the number of patients with the best efficacy evaluation of CR or PR during the process from enrollment to disease progression accounts for the proportion of the total number of evaluable patients.
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.
Progressive survival (PFS)
The time from enrollment and disease progression (PD) confirmed by imaging from enrollment to the first time (RECIST 1.1 criteria) or death without progress is recorded but due to any cause.
Time frame: From the enrollment to the progression of all CNS target lesions assessed according to RECIST standard up to 1 year.
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