adebrelimab combined with dalpiciclib and standard endocrine therapy for hr+/her2 - advanced breast cancer

Conditions: Breast Cancer

Summary: 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.


Eligibility criteria:
inclusion criteria: 1. premenopausal/perimenopausal or postmenopausal women aged ≥18 years and ≤75 years; 2. histologically confirmed hr+/her2- invasive breast cancer (specific definition: er \>10% tumor cell positive is defined as er positive, pr \>10% tumor cell positive is defined as pr positive, er and/or pr positive is defined as hr positive; her2 0-1+ or her2 ++ but negative by fish test, no amplification, defined as her2 negative); 3. locally advanced breast cancer (radical local treatment is not possible) or recurrent metastatic breast cancer; 4. did not receive any systemic anti-cancer therapy at the stage of recurrence and metastasis or failed to receive first-line endocrine therapy at the advanced stage; 5. allowed to receive ≤1 line of chemotherapy 6. have at least one measurable lesion according to recist version 1.1 7. adequate hematology and organ function, including: hemoglobin \> 9 g/dl without blood transfusion or erythropoietin in the past 14 days. anc ≥ 1.5×109/l without using granulocyte colony stimulating factor in the past 14 days. plt ≥ 75×109/l without blood transfusion in the past 14 days. tbil ≤ 1.5 ×uln (gilbert syndrome allows ≤ 3 × uln). alt and ast ≤ 3 × uln (if there is liver metastasis, alt and ast ≤ 5 × uln). serum cr ≤ 1.5 × uln or endogenous creatinine clearance ≥ 50 ml/min (cockcroft-gault formula) 8. ecog score 0 or 1, and life expectancy ≥3 months; 9. fertile female subjects are required to use a medically approved contraceptive during the study treatment period and for at least 3 months after the last use of the study drug; 10. subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up. exclusion criteria: 1. previous use of cdk4/6 inhibitors or pd1/pd-l1 monoclonal antibody 2. uncontrolled central nervous system metastasis (meaning symptoms or the use of glucocorticoids or mannitol to control symptoms); 3. a history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia; 4. radiotherapy, surgery, or other targeted and immunotherapy for advanced hr+/her2- breast cancer within 4 weeks prior to first administration of the study drug; 5. pregnant or lactating patients; 6. malignant tumors within the past three years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ); 7. significant comorbidities, including mental illnesses that the investigator believes will adversely affect the patient's participation in the study; 8. those who have received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug; 9. patients with known hbv or hcv infection active phase or hbv dna≥500, or chronic phase with abnormal liver function; 10. history of active autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes) 11. a history of immunodeficiency, including hiv testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; history of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia; 12. patients with active infection or who had been treated with systemic immune stimulating factors within 4 weeks prior to enrollment; 13. allergic physique, or known allergic history of the drug components of this program; or allergic to other monoclonal antibodies; 14. previous thyroid dysfunction; 15. the investigator did not consider the patient suitable for participation in any other conditions of the study

Keywords: hr+/her2- breast cancer adebrelimab dalpiciclib