Approximately 104 subjects with recurrent or metastatic IM triple negative breast cancer were planned to be included in the study, and screened eligible subjects were randomly assigned in a 1:1 ratio to treatment with the combination of Camrelizumab and investigator's choice of chemotherapy (test arm), treatment with investigator's choice of chemotherapy (control arm), and the stratification factor was liver metastasis (with vs without). After enrollment, subjects in the test group were treated with Camrelizumab 200 mg IV every 3 weeks for one cycle. The investigator's choice of single agent chemotherapy regimen (capecitabine, eribulin, gemcitabine, or vinorelbine) was every 3 weeks for one cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation at the investigator's discretion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Camrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine
Capecitabine or eribulin or gemcitabine or vinorelbine
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Progression free survival (PFS)
assessed by independent imaging (IRC), according to RECIST v1.1
Time frame: Treatment was assessed every 6 weeks after treatment initiation(up to 30 weeks), regardless of whether treatment was delayed or interrupted, until disease progression or study end, whichever occurred first.
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