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.