NCT06599216

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

Adebrelimab Combined With Dalpicicliband Standard Endocrine Therapy for HR + / HER 2-breast Cancer:A Single-center,Open-label,Single-arm Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to explore the efficacy and safety of PD-L1 inhibitor Adebrelimab combined with the CDK4/6 inhibitor Dalpcicilib and standard endocrine therapy given as neoadjuvant treatment in stages II-III hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Detailed description

This single-center, open-label, single-arm clinical trial aims to evaluate the efficacy and safety of the neoadjuvant treatment with the PD-L1 inhibitor Adebrelimab in combination with the CDK4/6 inhibitor Dalpicicilib in combination with standard endocrine therapy, for stages II-III hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Conditions

• Breast Cancer
• HR+/HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab+Dalpciclib+Standard Endocrine Therapy	Adebrelimab: 1200mg, intravenously, Q4w Dalpiciclib: 150mg once a day for 3 weeks, stop for 1 week, Q4w Standard Endocrine Therapy: Choice of endocrine therapy is according to guidelines and centre policy by investigator

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-03-01
• Completion: 2027-09-01
• First posted: 2024-09-19
• Last updated: 2025-08-21

Locations

2 sites across 1 country: China