This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Fudan University Shanghai Cancer Center
Shanghai, China
Occurrence of adverse events (AEs)- Phase 1
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
Time frame: Up to follow-up period, approximately 24 months
Objective Response Rate (ORR)- Phase 2
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Time frame: Until progression, assessed up to approximately 24 months
Progression Free Survival (PFS
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Time frame: Until progression, assessed up to approximately 24 months
Overall Survival (OS)
time to death due to any cause
Time frame: Until death, assessed up to approximately 24 months
Duration of Response (DoR)
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Time frame: Until progression, assessed up to approximately 24 months
Disease Control Rate (DCR)
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
Time frame: Baseline through end of study, assessed up to 24 months
Clinical Benefit Rate (CBR)
The percentage of subjects with CR, PR and SD≥24 weeks,as determined by the Investigator at local site per RECIST 1.1.
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Time frame: Until progression or death, assessed up to approximately 24 months
Exploratory analyses
HER2-PET was done at baseline to further explore the clinical utility of HER2-PET for HER2 detection
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 24 months
Safety
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Time frame: Up to follow-up period, approximately 24 months