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

April 7, 2025 updated by: The First Affiliated Hospital with Nanjing Medical University

Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer: a Multi-center, Real-world Study

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
BMI < 25.0 kg/m²
Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety
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 2
BMI ≥ 25.0 kg/m²
Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: It is defined as the time from the start of treatment to death for any reason, whichever came first, assessed up to 100 months
It is defined as the time from the start of treatment to death for any reason.
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)
Time Frame: 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 overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
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
Time Frame: 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
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMELIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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