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Comparing blood levels of the free‑DXd payload from trastuzumab‑deruxtecan by BMI in people with advanced or metastatic breast cancer

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

Phase 4 Interventional Institut Claudius Regaud · NCT07195344

This study will test whether body mass index changes blood levels of the free‑DXd payload in adults with locally advanced or metastatic HER2‑low or HER2‑positive breast cancer who are receiving trastuzumab‑deruxtecan.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years and up
SexAll
SponsorInstitut Claudius Regaud Academic / other
Drugs / interventionsTrastuzumab, pertuzumab
Locations11 sites (Angers and 10 other locations)
Trial IDNCT07195344 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, non-randomized, open‑label pharmacokinetic study that will collect serial blood samples to measure free‑DXd during the first three cycles of trastuzumab‑deruxtecan. The primary comparison is between two BMI groups (BMI ≤ 25 and BMI > 25), with 210 patients planned overall and at least 30 patients who are obese (BMI > 30) in the higher‑BMI group. Eligible participants include adults with histologically proven locally advanced or metastatic breast cancer with HER2 overexpression or low HER2 expression who are eligible for T‑DxD; concomitant pertuzumab may be allowed per local practice. The study will be conducted at multiple cancer centers in France and focuses on pharmacokinetic differences rather than clinical efficacy endpoints.

Who should consider this trial

Good fit: Adults (men or women) with histologically proven locally advanced or metastatic HER2‑low or HER2‑overexpressed breast cancer who are eligible to receive trastuzumab‑deruxtecan and are willing to undergo serial blood sampling are ideal candidates.

Not a fit: Patients not receiving trastuzumab‑deruxtecan, those with early‑stage disease, those unable to comply with serial blood draws, or those with medical conditions that profoundly alter drug pharmacokinetics may not gain direct benefit from this study.

Why it matters

Potential benefit: If successful, the results could help personalize dosing or monitoring of trastuzumab‑deruxtecan to improve treatment safety and effectiveness for patients across BMI groups.

How similar studies have performed: Pharmacokinetic work has characterized exposure to trastuzumab‑deruxtecan and other antibody‑drug conjugates, but direct comparisons of free‑DXd exposure by BMI are limited, making this a relatively novel question.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.
2. 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).
3. Patient eligible for Trastuzumab-Deruxtecan (T-DXd).
4. Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer.
5. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.
6. 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.

   Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.
7. 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.
8. Signed written informed consent.
9. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
10. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Peripheral venous access making blood samples difficult.
2. Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason)
3. 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.
4. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
5. Patient pregnant, or breast-feeding.
6. 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.
7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
8. Concurrent participation in an experimental drug study.
9. 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.
10. Patient with severe hepatic impairment defined by TGO and/or TGP \> 5 x ULN and Total bilirubin \> 1.5 x ULN.

Where this trial is running

Angers and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced or Metastatic Breast CancersLocally or metastatic Breast CancerHER2 low-expressedHER2 over-expressed/amplifiedTrastuzumab-DeruxtecanBody Mass IndexPharmacokinetics
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.