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

Institut Curie

Status: Begins enrollment in 1 month

Conditions: Breast Cancer

Treatments: Other: Capillary samples using the VAMS Mitra device

Study type: Interventional

Funder types: Other

Identifiers

NCT07491380

IC 2025-03

ID RCB: 2025-A01797-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Blood samples collection in breast cancer in patients receiving CDK4/6 inhibitors

Experimental group

Description:

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.

Treatment:

Other: Capillary samples using the VAMS Mitra device