NCT07491380

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
32mo left

Started May 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2028

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2028

Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 18, 2026

Last Update Submit

April 13, 2026

Conditions

Breast Cancer

Keywords

Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment

Outcome Measures

Primary Outcomes (1)

  • Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling.

    The primary objective of the study is therefore to validate the reliability of capillary sampling (using the VAMS Mitra device) as an alternative to venous sampling for TDM of CDK4/6 inhibitors (ribociclib, abemaciclib, or palbociclib) in breast cancer patients. The primary endpoint will be the concordance between drug concentrations obtained from venous and capillary samples, assessed through Bland-Altman analysis.

    Day 1

Secondary Outcomes (2)

  • Intra-patient's variability of the measurements from microsamplings

    Day 1

  • Acceptability of the device, as assessed by a patient satisfaction questionnaire.

    Day 1

Study Arms (1)

Blood samples collection in breast cancer in patients receiving CDK4/6 inhibitors

EXPERIMENTAL

Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen). The patients will also complete an acceptability Questionnaire following the samplings.

Other: Capillary samples using the VAMS Mitra device

Interventions

Capillary samples using the VAMS Mitra deviceOTHER

Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen). * 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse then 2 samples collected by the patient. * 1 venous sample (5 mL heparinized tube).

Also known as: Venous sample
Blood samples collection in breast cancer in patients receiving CDK4/6 inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Curie Paris

Paris, 75005, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Manon Launay, PH

    Institut Curie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Emmanuelle Legrier

CONTACT

0033156245649drci.promotion@curie.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Measurement of the concordance between the drug concentrations obtained from capillary and venous samplings
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2028

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(2)