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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Capillary samples using the VAMS Mitra device for Breast Cancer

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.

Official registry: https://clinicaltrials.gov/study/NCT07491380 · Institut Curie · enrollment listed as 90

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Capillary samples using the VAMS Mitra device. The registry lists allocation as na. 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.

They plan to enroll about 90 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Interventions: Capillary samples using the VAMS Mitra device

Primary outcome (registry wording): Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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 ability to comply with protocol requirements
  • Patients covered by a health insurance system

Public study contact (from the registry)

Marie-Emmanuelle Legrier

0033156245649

drci.promotion@curie.fr

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT07491380 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07491380?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07491380?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary