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Trial Title:
Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
NCT ID:
NCT06149130
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR+/HER2- breast cancer
adebrelimab
dalpiciclib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
adebrelimab:1200mg intravenously, Q3W.
Arm group label:
treatment group
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
dalpiciclib
Description:
dalpiciclib:150mg once a day for 3 weeks and stop for 1 week. Q4W.
Arm group label:
treatment group
Other name:
SHR-6390
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Huihua Xiong, PI
Phone:
027-83663405
Email:
xionghuihua@hotmail.com
Investigator:
Last name:
Huihua Xiong, PI
Email:
Principal Investigator
Start date:
January 11, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149130
