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

NCT07491380

RecruitingNA

Sponsor: Institut Curie

Conditions: Breast Cancer

Interventions: Capillary samples using the VAMS Mitra device

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

Paris, France
Saint-Cloud, France