OncoMatch/Clinical Trials/NCT06149130
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
Is NCT06149130 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06149130 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor, anti-PD-1 therapy, targeted therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify