Clinical trial NCT06926088: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer
Official title: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer: a Multi-center, Real-world Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Breast Cancer
Keywords: BMI
CDK4/6 Inhibitors
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: It is defined as the time from the start of treatment to death for any reason, whichever came first, assessed up to 100 months
measure: Objective Response Rate (ORR)
timeFrame: From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: The Number of Participants Who Experienced Adverse Events
timeFrame: From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References: