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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Capillary samples using the VAMS Mitra device

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators