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.
18 years to 75 years old, female patients with breast cancer;
ECOG PS Score: 0~1;
Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;
PD-L1 positive;
Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;
Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;
Prior anti-TROP-2 treatment;
Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;
Single group
SHR-A1921
DrugAnti-TROP-2 ADC
Adebrelimab
DrugPD-L1 inhibitor
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.
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.
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.
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).
OS (Overall Survival)
OS is the time from the date of first dose until the date of death by any cause.
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