Home-capillary blood sampling to monitor CDK4/6 inhibitors in breast cancer
Official title: Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
Run by Institut Curie · NCT07491380 · Data updated 2026-11-12
This study tests whether fingertip capillary samples collected at home can reliably measure drug levels for breast cancer patients treated with ribociclib, abemaciclib, or palbociclib, compared with standard venous draws.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Institut Curie Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | January 23, 2028 |
| Study ends | January 23, 2029 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07491380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with breast cancer currently treated with ribociclib, abemaciclib, or palbociclib who can perform or learn capillary sampling.
✕Probably not a fit
Patients unable to perform capillary sampling or whose pharmacokinetics differ markedly between capillary and venous samples may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, open-label, single-arm study evaluating the concordance between capillary microsampling using the VAMS Mitra device and traditional venous sampling for therapeutic drug monitoring in patients receiving CDK4/6 inhibitors. The goal is to determine if home-based fingertip sampling can reliably reflect drug concentrations to support personalized treatment. Five samples are collected at a single time point during the treatment period: four capillary samples (two collected by the patient with nurse training and two self-collected) and one venous sample. The treatment duration remains as per the prescribed CDK4/6 regimen. If capillary sampling proves reliable, this approach could reduce the burden of repeated blood draws while maintaining monitoring accuracy.
Why it matters
Potential benefit: If successful, patients could see more convenient, at-home monitoring with similar accuracy to venous sampling, potentially improving adherence and outcomes.
How similar studies have gone: Previous work in capillary microsampling suggests potential concordance with venous methods, but this study is among the first focused on CDK4/6 inhibitors in breast cancer.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Institut Curie Paris
Paris, France Recruiting -
Institut Curie
Saint-Cloud, France Not yet recruiting
Study contacts
- Principal investigator: Manon Launay, PH — Institut Curie
- Study coordinator: Marie-Emmanuelle Legrier
- Email: drci.promotion@curie.fr
- Phone: 0033156245649
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.