This study intends to explore the efficacy and safety of PD-L1 inhibitor Adebrelimab combined with the CDK4/6 inhibitor Dalpcicilib and standard endocrine therapy given as neoadjuvant treatment in stages II-III hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
This single-center, open-label, single-arm clinical trial aims to evaluate the efficacy and safety of the neoadjuvant treatment with the PD-L1 inhibitor Adebrelimab in combination with the CDK4/6 inhibitor Dalpicicilib in combination with standard endocrine therapy, for stages II-III hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adebrelimab: 1200mg, intravenously, Q4w Dalpiciclib: 150mg once a day for 3 weeks, stop for 1 week, Q4w Standard Endocrine Therapy: Choice of endocrine therapy is according to guidelines and centre policy by investigator
Harbin Medical Cancer Hospital
Harbin, Heilongjiang, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
tpCR rate
Total pathologic complete response (tpCR) rate, defined as ypT0/is, ypN0 as assessed by investigator.
Time frame: through study completion, an average of one and a half years
OS
OS is defined as the time between enrollment and the patient\'s death due to any cause.
Time frame: up to 3 years
EFS
Event-Free Survival (EFS) is defined as the time from firest dose to disease progression, disease recurrence, or death, whichever comes first.
Time frame: up to 3 years
Ki67
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Time frame: Baseline and At Surgery
ORR
Objective response rate(ORR) is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.
Time frame: Baseline up to Cycle 5(each cycle is 28 days)
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