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

• Sponsor: Tongji Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06149130
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Adebrelimab; Drug: dalpiciclib	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer:a Single-arm, Phase II Exploratory Clinical Study
• Anticipated Study Start Date: Nov 30, 2023
• Anticipated Primary Completion Date: Nov 30, 2025
• Anticipated Study Completion Date: Nov 30, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: treatment group Adebrelimab: 1200mg intravenously ,Q3W dalpiciclib : 150mg once a day for 3 weeks, stop for 1 week, Q4W Endocrine recommended drugs untreated: aromatase inhibitors (letrozole/anastrozole/exemestane), given orally once daily at a specific dose (letrozole 2.5mg/ day; Anastrozole 1mg/ day, exemestane 25mg/ day); first-line endocrine therapy failed: fluvestrant was given once every 28 days, 500mg intramuscular injection, and then 500mg intramuscular injection 2 weeks after the first administration;

Drug: Adebrelimab; adebrelimab:1200mg intravenously, Q3W.; Other Names: SHR-1316 ; Drug: dalpiciclib; dalpiciclib:150mg once a day for 3 weeks and stop for 1 week. Q4W.; Other Names: SHR-6390

Outcome Measures

Primary Outcome Measures

1. Progression-free survival(PFS) [Up to 3 years]

   PFS is defined as the time from enrollment to the first imaging disease progression or death (whichever occurs first). Assessed according to RECIST v1.1 by investigator.

Secondary Outcome Measures

1. Objective response rate (ORR) [Up to 3 years]

   ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.

2. Overall survival (OS) [Up to 5 years]

   OS is defined as the time between enrollment and the patient's death due to any OS is defined as the time between enrollment and the patient's death due to any cause

3. Safety and Tolerability [Up to 3 years]

   Safety includes the adverse event profile of sintilimab and bevacizumab according to the Common Terminology Criteria for Adverse Events version 5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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);

1. Locally advanced breast cancer (radical local treatment is not possible) or recurrent metastatic breast cancer;

2. 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;

3. Have at least one measurable lesion according to RECIST version 1.1

4. 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)

1. ECOG score 0 or 1, and life expectancy ≥3 months;

2. 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;

3. 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, chemotherapy, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huihua Xiong, Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT06149130
• Other Study ID Numbers: TJ-IRB20231105
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Huihua Xiong, Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology, Tongji Hospital: HR+/HER2- breast cancer; adebrelimab; dalpiciclib
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Nov 28, 2023