Clinical trial NCT06149130: Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
Official title: Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer:a Single-arm, Phase II Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: HR+/HER2- breast cancer
adebrelimab
dalpiciclib
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 3 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
Study officials:
References: