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

Nanjing Medical University

Status

Active, not recruiting

Conditions

Advanced Breast Cancer

Treatments

Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety

Study type

Observational

Funder types

Other

Identifiers

NCT06926088

CAMELIA

Details and patient eligibility

About

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

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.