Recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

8 criteria

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 trial?

15 criteria

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)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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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.

Trastuzumab Deruxtecan

What is already known about the treatment

Trastuzumab-Deruxtecan (T-DXd) - An advanced antibody-drug conjugate administered through intravenous infusion, specifically designed for treating metastatic breast cancer. This medication combines trastuzumab, which targets HER2-positive cancer cells, with deruxtecan, a potent chemotherapy agent that is released inside cancer cells. The drug works by delivering the chemotherapy component directly to cancer cells that express the HER2 protein on their surface, while minimizing damage to healthy cells. As a relatively new treatment in oncology, it represents an important advancement in targeted therapy for patients with metastatic breast cancer who have limited treatment options, particularly when traditional therapies have proven ineffective.

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.