Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Anti-TROP-2 ADC
PD-L1 inhibitor
Fudan Cancer Hospital
Shanghai, Shanghai Municipality, China
ORR by investigator
ORR (Objective response rate) 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: At baseline, at the time point of every 6 weeks, up to 2 years
DCR by investigator
DCR (Disease control rate) 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: At baseline, at the time point of every 6 weeks, up to 2 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 2 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: Up to 2 years
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 2 years
Safety (incidence rate of adverse event)
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: From time of informed consent provided to 3 months after the last dose of study therapy
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