Combination treatment for advanced HR+/HER2- breast cancer

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

This study is testing a new combination of treatments for people with advanced HR+/HER2- breast cancer to see if it can help them feel better after their previous treatments didn't work.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, adebrelimab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06149130 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial investigates the efficacy and safety of adebrelimab, a PD-L1 inhibitor, combined with dalpiciclib, a CDK4/6 inhibitor, and standard endocrine therapy in patients with advanced HR+/HER2- breast cancer. The study focuses on individuals who have not received systemic anti-cancer therapy at the stage of recurrence or have failed first-line endocrine therapy. It is a prospective, single-arm, multicenter trial aimed at evaluating the potential benefits of this combination treatment in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include premenopausal, perimenopausal, or postmenopausal women aged 18 to 75 with advanced HR+/HER2- breast cancer who have not received prior systemic therapy.

Not a fit: Patients who have received multiple lines of systemic anti-cancer therapy or have HER2 positive breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced HR+/HER2- breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of PD-L1 and CDK4/6 inhibitors in breast cancer, indicating potential for success.

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

Where this trial is running

Wuhan, Hubei

• Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiong huihua

Conditions Breast Cancer; HR+/HER2- breast cancer; adebrelimab; dalpiciclib