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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Oscar Lambret
  Lille, France Recruiting
• CHU de Nîmes
  Nîmes, France Recruiting
• Institut Curie - Site Paris
  Paris, France Recruiting
• Centre Eugène Marquis
  Rennes, France Recruiting
• Centre Paul Strauss
  Strasbourg, France Recruiting
• Iuct-O
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Florence DALENC, MD, Prof
• Email: dalenc.florence@iuct-oncopole.fr
• Phone: +33531155104

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.