Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME) (TDHOME)
Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie-Emmanuelle Legrier
- Phone Number: 0033156245649
- Email: drci.promotion@curie.fr
Study Locations
-
-
-
Paris, France, 75005
- Recruiting
- Institut Curie Paris
-
Contact:
- Audrey BELLESOEUR
-
Principal Investigator:
- Audrey BELLESOEUR
-
Saint-Cloud, France, 92210
- Not yet recruiting
- Institut CURIE
-
Contact:
- Bringuier MICHAEL
-
Principal Investigator:
- Bringuier MICHAEL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients (≥ 18 years) with breast cancer.
- Patients currently receiving ribociclib, abemaciclib, or palbociclib.
- Patients capable of performing capillary sampling (with or without assistance).
- Patient information and signing of informed consent.
- Patient ability to comply with protocol requirements.
- Patients covered by a health insurance system.
Exclusion Criteria:
- Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
- Persons deprived of their liberty or under guardianship.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood samples collection in breast cancer in patients receiving CDK4/6 inhibitors
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). The patients will also complete an acceptability Questionnaire following the samplings. |
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.
Time Frame: 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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intra-patient's variability of the measurements from microsamplings
Time Frame: 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.
|
Day 1
|
|
Acceptability of the device, as assessed by a patient satisfaction questionnaire.
Time Frame: 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).
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manon Launay, PH, Institut CURIE
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC 2025-03
- ID RCB: 2025-A01797-42 (Other Identifier: Institut Curie)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.