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.
Therapeutic drug monitoring (TDM) could serve as a valuable tool to minimize adverse events and maximize the efficacy of treatment in breast cancer patients receiving CDK4/6 inhibitors (ribociclib, abemaciclib, palbociclib). However, current TDM performed via venous blood draws can be inconvenient, especially for repeated sampling. This study aims to evaluate the reliability of capillary (fingertip) microsampling-which could be performed at home as a less invasive alternative to standard venous sampling for measuring residual drug concentrations. 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 who will train the patient to perform the 2 following samples him/herself; and 1 venous sample (5 mL heparinized tube).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
90
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).
Institut Curie Paris
Paris, France
Institut Curie
Saint-Cloud, France
Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.
The primary objective of the study is therefore to validate the reliability of capillary sampling (using the VAMS Mitra device) as an alternative to venous sampling for TDM of CDK4/6 inhibitors (ribociclib, abemaciclib, or palbociclib) in breast cancer patients. The primary endpoint will be the concordance between drug concentrations obtained from venous and capillary samples, assessed through Bland-Altman analysis.
Time frame: Day 1
Intra-patient's variability of the measurements from microsamplings
Reproducibility of capillary microsampling will be evaluated from the four replicate VAMS collections (two patient-collected, two nurse-collected). We will estimate within-patient variability as the coefficient of variation (CV %) across replicates and report duplicate %-difference.
Time frame: Day 1
Acceptability of the device, as assessed by a patient satisfaction questionnaire.
A satisfaction questionnaire for the use of VAMS-type microsampling device will be completed by the patient after the samples collection. Patient acceptability and usability of VAMS will be summarized descriptively with exploratory comparisons by age, sex, and collection setting (clinic vs home where applicable).
Time frame: Day 1
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