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NCT Number: NCT06926088

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: CAMELIA

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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