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Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)
Sponsor: Institut Curie
Summary
This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.
Official title: Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-06-23
Completion Date
2029-01-23
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Capillary samples using the VAMS Mitra device
Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen). * 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse then 2 samples collected by the patient. * 1 venous sample (5 mL heparinized tube).
Locations (2)
Institut Curie Paris
Paris, France
Institut Curie
Saint-Cloud, France