Breast Cancer
Conditions
Keywords
Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment
Brief 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.
Detailed description
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).
Interventions
OTHERCapillary 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).
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Measurement of the concordance between the drug concentrations obtained from capillary and venous samplings
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (≥ 18 years) with breast cancer. 2. Patients currently receiving ribociclib, abemaciclib, or palbociclib. 3. Patients capable of performing capillary sampling (with or without assistance). 4. Patient information and signing of informed consent. 5. Patient ability to comply with protocol requirements. 6. Patients covered by a health insurance system.
Exclusion criteria
1. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent. 2. Persons deprived of their liberty or under guardianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling. | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-patient's variability of the measurements from microsamplings | Day 1 | 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. |
| Acceptability of the device, as assessed by a patient satisfaction questionnaire. | Day 1 | 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). |
Countries
France
Contacts
CONTACTMarie-Emmanuelle Legrier
PRINCIPAL_INVESTIGATORManon Launay, PH
Institut Curie
Outcome results
None listed