Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)
Recruiting · NCT07491380 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Curie
View the official record on ClinicalTrials.gov →Interventions studied
Capillary samples using the VAMS Mitra device
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Institut Curie Paris - Paris, France
- Institut Curie - Saint-Cloud, France