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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.

Study acronym: TDXdose
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Study sites: 11 to 10
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Site details revised at 1 of 11 sitesv6
  3. Site details revised at 1 of 11 sitesv5
  4. Study sites: 10 to 11v4
  5. Study sites: 9 to 10v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2025 to Oct 15, 2025
    • Site details revised at 9 of 9 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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). 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).
Trial Details
NCT Number NCT07195344
Lead Sponsor Institut Claudius Regaud
Collaborators: Ligue contre le cancer, France
Conditions
(from sponsor)		 Locally Advanced or Metastatic Breast Cancers
Related terms Breast Neoplasms
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov