OncoMatch/Clinical Trials/NCT06149130
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
Is NCT06149130 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Adebrelimab and dalpiciclib for breast cancer.
Treatment: Adebrelimab · dalpiciclib — This is a prospective, single-arm, multicenter Phase II study of patients with advanced HR+/HER2- breast cancer who are untreated or have failed previous first-line endocrine therapy。The primary objective of this study was to explore the efficacy and safety of the PD-L1 inhibitor adebrelimab in combination with the CDK4/6 inhibitor Dalpiciclib and standard endocrine therapy in advanced HR+/ HER2-breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER >10% tumor cell positive)
ER >10% tumor cell positive is defined as ER positive
Required: PR (PGR) overexpression (PR >10% tumor cell positive)
PR >10% tumor cell positive is defined as PR positive
Required: HER2 (ERBB2) wild-type (HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification)
HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: CDK4/6 inhibitor
Previous use of CDK4/6 inhibitors
Cannot have received: anti-PD-1 therapy
Previous use of PD1/PD-L1 monoclonal antibody
Cannot have received: targeted therapy
Exception: within 4 weeks prior to first administration of the study drug
other targeted and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks prior to first administration of the study drug
Cannot have received: immunotherapy
Exception: within 4 weeks prior to first administration of the study drug
other targeted and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks prior to first administration of the study drug
Cannot have received: radiation therapy
Exception: within 4 weeks prior to first administration of the study drug
Radiotherapy...within 4 weeks prior to first administration of the study drug
Cannot have received: surgery
Exception: within 4 weeks prior to first administration of the study drug
surgery...within 4 weeks prior to first administration of the study drug
Cannot have received: anti-tumor vaccine
Exception: within 4 weeks before the first administration of the investigational drug
received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug
Cannot have received: live vaccine
Exception: within 4 weeks before the first administration of the investigational drug
received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug
Lab requirements
Blood counts
hemoglobin > 9 g/dl without blood transfusion or erythropoietin in the past 14 days; anc ≥ 1.5×10^9/l without using granulocyte colony stimulating factor in the past 14 days; plt ≥ 75×10^9/l without blood transfusion in the past 14 days
Kidney function
serum cr ≤ 1.5 × uln or endogenous creatinine clearance ≥ 50 ml/min (cockcroft-gault formula)
Liver function
tbil ≤ 1.5 ×uln (gilbert syndrome allows ≤ 3 × uln). alt and ast ≤ 3 × uln (if there is liver metastasis, alt and ast ≤ 5 × uln)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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