NCT06149130

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab	adebrelimab:1200mg intravenously, Q3W.
DRUG	dalpiciclib	dalpiciclib:150mg once a day for 3 weeks and stop for 1 week. Q4W.

Timeline

• Start date: 2024-01-11
• Primary completion: 2025-11-30
• Completion: 2026-11-30
• First posted: 2023-11-28
• Last updated: 2024-04-15

Locations

1 site across 1 country: China