NCT06926088

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer: a Multi-center, Real-world Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.

Detailed description

Body mass index (BMI) is strongly associated with the development and progression of breast cancer. Despite the widespread use of cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) in hormone receptor (HR)-positive advanced breast cancer, the effect of BMI on therapeutic outcomes remains poorly understood. Here, we present real-world evidence to substantiate the association between BMI and CDK4/6 inhibitors efficacy and safety.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety	Patients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study.

Timeline

• Start date: 2016-12-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-04-13
• Last updated: 2025-04-13

Locations

1 site across 1 country: China