Status:
ACTIVE_NOT_RECRUITING
Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Advanced Breast Cancer
Eligibility:
All Genders
18-99 years
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06926088
Start Date
December 1 2016
End Date
March 1 2026
Last Update
April 13 2025
Active Locations (1)
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1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China