Breast CancerTDHOMENCT07491380
Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)
A study testing Capillary samples using the VAMS Mitra device in people with Breast Cancer, run by Institut Curie at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capillary samples using the VAMS Mitra device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jun 2026to 23 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Institut Curie Paris
Paris, 75005
Audrey BELLESOEUR
Audrey BELLESOEUR
- Not yet recruiting
Institut Curie
Saint-Cloud, 92210
Bringuier MICHAEL
Bringuier MICHAEL
About this study
Official title: Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients
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.
Read the detailed description
Therapeutic drug monitoring (TDM) could serve as a valuable tool to minimize adverse events and maximize the efficacy of treatment in breast cancer patients receiving CDK4/6 inhibitors (ribociclib, abemaciclib, palbociclib). However, current TDM performed via venous blood draws can be inconvenient, especially for repeated sampling.
This study aims to evaluate the reliability of capillary (fingertip) microsampling-which could be performed at home as a less invasive alternative to standard venous sampling for measuring residual drug concentrations.
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 who will train the patient to perform the 2 following samples him/herself; and 1 venous sample (5 mL heparinized tube).
- Conditions
- Breast Cancer
- Being tested
- Capillary samples using the VAMS Mitra device
- Keywords
- Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary samples using the VAMS Mitra deviceOther
Also called Venous sample
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Capillary samples using the VAMS Mitra device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Intra-patient's variability of the measurements from microsamplings
Reproducibility of capillary microsampling will be evaluated from the four replicate VAMS collections (two patient-collected, two nurse-collected). We will estimate within-patient variability as the coefficient of variation (CV %) across replicates and report duplicate %-difference.
Measured: Day 1
Acceptability of the device, as assessed by a patient satisfaction questionnaire.
A satisfaction questionnaire for the use of VAMS-type microsampling device will be completed by the patient after the samples collection. Patient acceptability and usability of VAMS will be summarized descriptively with exploratory comparisons by age, sex, and collection setting (clinic vs home where applicable).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 Jun 2026 (estimated)
- Primary completion23 Jan 2028 (estimated)
- Study completion23 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Measurement of the concordance between the drug concentrations obtained from capillary and venous samplings
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon Launay, PH, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491380
- Sponsor's protocol ID
- IC 2025-03
- Other IDs
- ID RCB: 2025-A01797-42
- Acronym
- TDHOME
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.