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Locally Advanced or Metastatic Breast CancersPhase 4TDXdoseNCT07195344

Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.

A Phase 4 study testing Pharmacokinetics blood samples in people with Locally Advanced or Metastatic Breast Cancers, run by Institut Claudius Regaud at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their BMI. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pharmacokinetics blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
10 sitesFrance
Study dates
15 Oct 2025to Oct 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

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

  • Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.
  • Metastatic or locally advanced breast cancer with overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval).
  • Patient eligible for Trastuzumab-Deruxtecan (T-DXd).
  • Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer.
  • Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.
  • Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 7 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months.
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  • Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.
  • Male subjects must agree to use at least one method of contraception for the duration of the study and until 4 months after the last dose of study treatment.
  • Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.
  • Signed written informed consent.
  • Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
  • Patient affiliated to a Social Health Insurance in France.

Who cannot join

  • Peripheral venous access making blood samples difficult.
  • Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason)
  • Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
  • Patient pregnant, or breast-feeding.
  • Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
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  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
  • Concurrent participation in an experimental drug study.
  • Patient with a known history of hypersensitivity to the active substance of T-DXd or to any of the excipients listed in the SmPC of T-DXd.
  • Patient with severe hepatic impairment defined by TGO and/or TGP > 5 x ULN and Total bilirubin > 1.5 x ULN.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Florence DALENC, MD, Prof contact

+33531155104

dalenc.florence@iuct-oncopole.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • Institut de Cancérologie de l'Ouest - Site Angers

    Angers

    Anne Patsouris, MD, +33241352700, anne.patsouris@ico.unicancer.fr

    Not yet recruiting

  • Centre Georges François Leclerc

    Dijon

    Sylvain Ladoire, MD,Prof, +33380737506, sladoire@cgfl.fr

    Not yet recruiting

  • Centre Oscar Lambret

    Lille

    Coralie PREBET, MD, +33 320295959, c-prebet@o-lambret.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Arthur Géraud-Crémieux, MD, +33491223333, geraudcremieuxa@ipc.unicancer.fr

    Not yet recruiting

  • CHU de Nîmes

    Nîmes

    Frédéric FITENI, MD, +33466683301, frederic.fiteni@chu-nimes.fr

    Recruiting

  • Institut Curie - Site Paris

    Paris

    Audrey Bellesoeur, MD, +33156245840, audrey.bellesoeur@curie.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Antoine Deleuze, MD, +33299252956, a.deleuze@rennes.unicancer.fr

    Recruiting

  • Centre Paul Strauss

    Strasbourg

    Hervé Bischoff, MD, +33368767099, h.bischoff@icans.eu

    Recruiting

  • IUCT-O

    Toulouse

    Florence DALENC, MD, Prof, +33531155104, dalenc.florence@iuct-oncopole.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

    Vincent MASSARD, MD, 03 83 59 84 61, v.massard@nancy.unicancer.fr

    Not yet recruiting

Other trials in France

About this study

Official title: Influence of Patient's Morphological Characteristics on Pharmacokinetic and Toxicity of Trastuzumab-Deruxtecan Administered for Metastatic Breast Cancers

This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their BMI.

The primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (BMI>25) and normal weight (BMI≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd).

Read more

A total of 210 patients will have to be enrolled in this study with the following repartition:

N = 105 patients with a BMI ≤ 25 (normal weight patients). N = 105 patients with a BMI > 25 (overweight or obese patients) with at least 30 obese patients (BMI>30).

Being tested
Pharmacokinetics blood samples
Keywords
Locally or metastatic Breast Cancer, HER2 low-expressed, HER2 over-expressed/amplified, Trastuzumab-Deruxtecan, Body Mass Index, Pharmacokinetics
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacokinetics blood samplesBiological

    Blood samples will be collected at different time points during the first four treatment cycles and at the end of T-DXd treatment or at 24 months after inclusion in case of T-DXd continuation beyond this time period.

Study groups in NCT07195344
Study groupRoleWhat they receive
Patient with locally advanced or metastatic breast cancer starting T-DXd as standard treatmentOtherNot described
Receives: Biological: Pharmacokinetics blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure

    Plasma exposure of free-DXd (payload) will be measured by the cumulative AUC (Area under the concentration vs. time curve) over the first 3 cycles or until an event (interruption or dose concession for toxicity) divided by the number of corresponding cycles.

    These AUCs will be determined by Bayesian estimation (Posthoc values) using a non-linear mixed-effects approach.

    Measured: From the 1st cycle of T-DXd (C1D1) to the end of the 3rd cycle of T-DXD (each cycle is 21 days) treatment or until an event (interruption or dose concession for toxicity) if it occurs before the 3rd cycle.

Secondary outcomes (4)

  1. Safety: toxicities will be assessed using the NCI-CTCAE Version 5.0.

    Measured: From enrollment to the end of patient participation up to 24 months after inclusion

  2. Efficacy: Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from inclusion until progression or death; patients alive and without documented progression at last follow-up news are censored at this date or at initiation of new anticancer treatment (if applicable).

    Measured: From inclusion until progression or death up to 24 months after inclusion

  3. Secondary pharmacokinetic criteria

    A population PK model will be performed to quantify the impact of several patient characteristics: morphological data (weight, height, BMI, lean mass, etc.), biological data (inflammation markers, albuminemia, liver enzymes, etc.), demographic data (age), on the PK parameters (elimination clearance, volume of distribution) of T-DXd and free-DXd.

    Measured: From C1D1 to definitive stop of T-DXd treatment up to 24 months after inclusion

  4. Body composition parameters

    Skeletal muscle mass index or density and lean body mass before treatment initiation and during the active treatment phase (at 3 months tumor assessment before C5D1 and at 6 months; tumor assessment before C9D1) using the "Cassandra" algorithm.

    Measured: From enrollment to tumor assessment before C9D1 at 6 months of T-DXd treatment (each cycle is 21 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start15 Oct 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

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 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195344
Sponsor's protocol ID
25SEIN06
Acronym
TDXdose
Status last verified
Oct 2025
First submitted
11 Sep 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pharmacokinetics blood samples in people with Locally Advanced or Metastatic Breast Cancers, run by Institut Claudius Regaud at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Florence DALENC, MD, Prof (+33531155104, dalenc.florence@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure (time frame: From the 1st cycle of T-DXd (C1D1) to the end of the 3rd cycle of T-DXD (each cycle is 21 days) treatment or until an event (interruption or dose concession for toxicity) if it occurs before the 3rd cycle.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07195344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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