This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
4.8 mg/kg for each 21 (±3) -day cycle
Objective response rate(ORR)
ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1.
Time frame: 2 years
Progression-free survival(PFS)
PFS is defined as the time between date of first dose of study therapy and date of progression or death according RECIST 1.1.
Time frame: 2 years
Disease control rate(DCR)
DCR is defined as cases where objective remission(assessed as complete remission or partial remission according RECIST 1.1 standard) or stable disease during the study.
Time frame: 2 years
Clinical benefit rate(CBR)
CBR is defined as the proportion of patients with a complete or partial response or with stable disease according RECIST 1.1
Time frame: 2 years
Duration of rate(DOR)
DOR is defined the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause according RECIST 1.1.
Time frame: 2 years
Time to response(TTR)
TTP is defined as the time between randomization and objective tumor progression according RECIST 1.1; TTP does not include death
Time frame: 2 years
Overall survival(OS)
Overall survival(OS) is defined as the time from first dose of study therapy to the date of death(any case).Subjects who are alive censored at the last known time that the subject was alive.
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Time frame: 2 years