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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Xiong huihua
xionghuihua@hotmail.com
027-83663405
Backup
Chao tengfei
turnface@126.com
027-83663409
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 82
Treatments
Experimental: treatment group
1. Adebrelimab: 1200mg intravenously ,Q3W~2. dalpiciclib : 150mg once a day for 3 weeks, stop for 1 week, Q4W~3. 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;
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov

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