Study of Trastuzumab Deruxtecan Blood Levels in Normal Weight and Overweight Patients with Metastatic Breast Cancer

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What is this study about?

This study focuses on patients with metastatic breast cancer who will receive treatment with trastuzumab deruxtecan (also known as T-DXd). The medication is given as an intravenous infusion. This type of breast cancer has spread to other parts of the body, and patients may have different levels of a protein called HER2 on their cancer cells.

The study aims to understand how a person’s body weight and size affect the way the medication works and what side effects it might cause. The medication will be given in treatment cycles, and researchers will measure the amount of medicine in the blood during the first three cycles of treatment.

During the study, patients will receive T-DXd through an infusion into their vein. Some patients may also receive another medication called pertuzumab along with their treatment. The study will last for up to 24 months, during which time patients will have regular check-ups to monitor their health and how well the treatment is working.

1 Initial treatment preparation

You will undergo a pregnancy test (if applicable) within 72 hours before starting the treatment

The treatment involves receiving Enhertu (trastuzumab deruxtecan) through an intravenous infusion

2 Treatment cycles

You will receive treatment over multiple cycles

During the first 3 cycles, blood samples will be collected to measure drug levels in your body

The medical team will monitor how your body processes the medication, particularly focusing on a component called DXd

3 Ongoing monitoring

Throughout the treatment, your health will be closely monitored for any side effects

Any side effects will be recorded using a standardized classification system

The medical team will track how well the treatment is working against your cancer

4 Safety measures

You must use appropriate contraception during the study period

If you are female, contraception must continue for 7 months after the last treatment

If you are male, contraception must continue for 4 months after the last treatment

5 Study duration

The study is planned to run from September 2025 to September 2029

Your individual participation duration will depend on how you respond to the treatment

Who Can Join the Study?

  • Must be at least 18 years old at the time of signing consent
  • Must have breast cancer confirmed by tissue examination
  • Must have either:
    – Advanced breast cancer that has spread (metastatic) or
    – Locally advanced breast cancer with specific HER2 protein levels (a protein that promotes cancer cell growth)
  • Must be eligible to receive the study medication Trastuzumab-Deruxtecan
  • For women who can become pregnant:
    – Must have a negative pregnancy test within 72 hours before starting treatment
    – Must use contraception or abstain from heterosexual activity during the study and for 7 months after the last dose
  • For men participating in the study:
    – Must use contraception during the study and for 4 months after the last dose
  • Must be willing and able to:
    – Sign an informed consent form
    – Follow study procedures
    – Comply with the study requirements
  • Must have active health insurance in France

Who Cannot Join the Study?

  • Age under 18 years old
  • Known allergy or hypersensitivity to Trastuzumab-Deruxtecan (a type of cancer medication) or any of its components
  • Pregnancy or breastfeeding
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart problems, including heart failure (when the heart cannot pump blood effectively)
  • Severe liver problems
  • Severe kidney problems
  • Active serious infections
  • Other active cancers requiring treatment
  • Major surgery within 4 weeks before starting the study
  • Participation in another clinical trial within 4 weeks before this study
  • Any medical condition that the doctor believes would make participation unsafe
  • Unable to follow study procedures or attend scheduled visits
  • History of severe allergic reactions to other similar medications
  • Severe lung problems or history of interstitial lung disease (a group of disorders that cause scarring of lung tissue)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Iasstpsp Pdeqdysnstntxxq Cuxxjt Czmcgj Marseille France
Cbdowc Ocpig Lxpisev Lille France
Igayppqv Cxhzp Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2025

Trial locations

Investigated drugs:

Trastuzumab-Deruxtecan (T-DXd) is a medication used to treat metastatic breast cancer. It is a type of targeted therapy known as an antibody-drug conjugate. This means it combines two parts: trastuzumab, which targets specific cancer cells, and deruxtecan, which is the part that kills the cancer cells. The medication works by delivering the cancer-fighting component directly to cancer cells that have a specific protein on their surface, helping to reduce damage to healthy cells.

Investigated diseases:

Metastatic Breast Cancer – A form of breast cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body. The cancer cells from the original tumor break away and travel through the bloodstream or lymphatic system to form new tumors in other organs. These secondary tumors, called metastases, most commonly develop in the bones, liver, lungs, or brain. The disease typically develops gradually, with cancer cells first spreading to nearby lymph nodes before reaching distant organs. The condition can affect various body functions depending on where the cancer spreads.

Trial ID:
2025-522656-68-00
Protocol code:
25 SEIN 06
Trial Phase:
Therapeutic confirmatory (Phase III)

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