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Recruiting NCT07491380

Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capillary samples using the VAMS Mitra device.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients

Overview

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

  • Other 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).

Primary outcome measures

  • Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling. [Time frame: Day 1]
Secondary outcome measures (2)
  • Intra-patient's variability of the measurements from microsamplings [Time frame: Day 1]
  • Acceptability of the device, as assessed by a patient satisfaction questionnaire. [Time frame: Day 1]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • Institut Curie Paris — Paris
  • Institut Curie — Saint-Cloud

Identifiers

NCT: NCT07491380 · IC 2025-03 · ID RCB: 2025-A01797-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗