Not Yet RecruitingNot Applicable

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

France90 participantsStarted 2026-05-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.

Timeframe: Day 1

Trial details

NCT IDNCT07491380

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-15

Contact for this trial

Marie-Emmanuelle Legrier

0033156245649 drci.promotion@curie.fr

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