Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Via intravenous infusion
Via intravenous infusion
Via intravenous infusion
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
RECRUITINGORR (objective response rate) by investigator
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
DCR (disease control rate) by investigator
DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
CBR (clinical benefit rate) by investigator
CBR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD lasting≥24 weeks (stable disease) per RECIST v1.1.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
DoR (duration of response)
DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.
Time frame: up to 3.5 years
PFS (progression-free survival)
PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
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Via intravenous infusion
OS (overall survival)
OS is the time from the date of first dose until the date of death by any cause.
Time frame: up to 3.5 years
Safety as assessed by percentage of patients with any Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.
Time frame: up to 3.5 years