NCT07019363

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)

A Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,903 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.

Conditions

• Breast Cancer
• Adjuvant Therapy

Interventions

Type	Name	Description
DRUG	Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)	Standard endocrine therapy
DRUG	Standard endocrine therapy combined with CDK4/6 Inhibitor	CDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy

Timeline

• Start date: 2025-06-15
• Primary completion: 2029-05-15
• Completion: 2033-04-15
• First posted: 2025-06-13
• Last updated: 2026-01-21

Locations

1 site across 1 country: China