The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
223
TKI
PD1 inhibitor
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPFS
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: max 6 months
DoR
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
Time frame: max 6 months
CBR
The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Time frame: max 6 months
OS
time to death due to any cause
Time frame: approximately 3 years
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