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

RecruitingNAAges 18 Years - anyAllInstitut Curie
NCT07491380 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Capillary samples using the VAMS Mitra device
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Where

2 sites
Institut Curie Paris
Paris, France
Institut Curie
Saint-Cloud, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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