This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SHR-A1921 + Bevacizumab
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
CNS ORR
The proportion of patients who have a CR or PR in the CNS, as determined by the Investigator according to RANO-BM criteria
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
CNS CBR
CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
Progression-free survival
PFS will be defined as the time from the first dose of treatment to death or disease progression
Time frame: Up to 2 years
Overall survival
OS will be defined as the time from the first dose of treatment to death for any cause
Time frame: Up to 2 years
First progression site
The first lesion to progress
Time frame: Up to 2 years
Safety as assessed by percentage of patients with any Adverse Event
Adverse event according to NCI-CTC AE 5.0
Time frame: Up to 2 years
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