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

NCT ID: NCT06926088

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

BMI \< 25.0 kg/m²

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety

Intervention Type: DRUG

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.

Group 2

BMI ≥ 25.0 kg/m²

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age and above;
• Women of any menstrual status;
• Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable;
• Patients with histological pathology that is clearly HR-positive/HER2-negative breast cancer, or if there is metastatic pathology, the histological pathology of the metastatic foci shall prevail. (Those with ER intensity >1% cellular nuclear staining)
• Patients have at least 3 more fully documented medical records at the enrolled centre, including at least 1 inpatient record.

Exclusion Criteria

• CDK4/6 inhibitors as neoadjuvant or adjuvant therapy;
• Significantly missing diagnostic and treatment data from patients' medical records;
• Participation in other clinical trials before and during the data collection period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

CAMELIA

Identifier Type: -

Identifier Source: org_study_id