Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer

Официальное название

Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer:a Single-arm, Phase II Exploratory Clinical Study

Обзор

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.

Вмешательства

• Препарат Adebrelimab
  adebrelimab:1200mg intravenously, Q3W.
• Препарат dalpiciclib
  dalpiciclib:150mg once a day for 3 weeks and stop for 1 week. Q4W.

Первичные конечные точки

• Progression-free survival(PFS) [Срок оценки: Up to 3 years]

Вторичные конечные точки (3)

• Objective response rate (ORR) [Срок оценки: Up to 3 years]
• Overall survival (OS) [Срок оценки: Up to 5 years]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Premenopausal/perimenopausal or postmenopausal women aged ≥18 years and ≤75 years;
• 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);
• Locally advanced breast cancer (radical local treatment is not possible) or recurrent metastatic breast cancer;
• 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;
• Allowed to receive ≤1 line of chemotherapy
• Have at least one measurable lesion according to RECIST version 1.1
• 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)

• ECOG score 0 or 1, and life expectancy ≥3 months;
• 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;
• Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

Критерии исключения

• Previous use of CDK4/6 inhibitors or PD1/PD-L1 monoclonal antibody
• Uncontrolled central nervous system metastasis (meaning symptoms or the use of glucocorticoids or mannitol to control symptoms);
• 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;
• Radiotherapy, surgery, or other targeted and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks prior to first administration of the study drug;
• Pregnant or lactating patients;
• Malignant tumors within the past three years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
• Significant comorbidities, including mental illnesses that the investigator believes will adversely affect the patient's participation in the study;
• Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the investigational drug;
• Patients with known HBV or HCV infection active phase or HBV DNA≥500, or chronic phase with abnormal liver function;
• 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)
• 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;
• Patients with active infection or who had been treated with systemic immune stimulating factors within 4 weeks prior to enrollment;
• Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
• Previous thyroid dysfunction;
• The investigator did not consider the patient suitable for participation in any other conditions of the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Te — Ухань

Идентификаторы

NCT: NCT06149130 · TJ-IRB20231105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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