Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Pharmacokinetics blood samples for Locally Advanced or Metastatic Breast Cancers

This is a multicenter, prospective, non-randomly assigned, 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 body-mass index (BMI). The primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (body-mass index (BMI)\>25) and normal weight (body-mass index (BMI)≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd).

Official registry: https://clinicaltrials.gov/study/NCT07195344 · Institut Claudius Regaud · enrollment listed as 210

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

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 Pharmacokinetics blood samples. The registry lists allocation as na. This is a multicenter, prospective, non-randomly assigned, 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 body-mass index (BMI).

They plan to enroll about 210 people at 10 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: Pharmacokinetics blood samples

Primary outcome (registry wording): Primary Outcome Measure

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • 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
  • Patient affiliated to a Social Health Insurance in France

Public study contact (from the registry)

Florence DALENC, MD, Prof

+33531155104

dalenc.florence@iuct-oncopole.fr

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

Sites listed on ClinicalTrials.gov

10 listed

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FAQ about this NCT record

Is NCT07195344 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 NCT07195344?

Phase 4. 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 NCT07195344?

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