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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Page 1 of 1 (1 locations)

1

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China