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

NCT06926088 | Active Not Recruiting DMC

• 1 other identifier: CAMELIA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer

Keywords

BMI; CDK4/6 Inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

  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 (3)

• Overall Survival (OS)

  It is defined as the time from the start of treatment to death for any reason, whichever came first, assessed up to 100 months

• Objective Response Rate (ORR)

  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

• The Number of Participants Who Experienced Adverse Events

  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

Study Arms (2)

Group 1

BMI \< 25.0 kg/m²

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

Group 2

BMI ≥ 25.0 kg/m²

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

Interventions

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety 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 1; Group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

Safety

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 13, 2025
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)