Study Comparing Trastuzumab Deruxtecan with Standard Treatment for Patients with HER2-positive Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as HER2-positive breast cancer. This is a form of cancer where the cancer cells have more of a protein called HER2, which can make the cancer grow more quickly. The study is testing a treatment called trastuzumab deruxtecan, also known by its code name T-DXd. This treatment is being compared to standard treatments to see which is more effective in achieving a complete response, meaning no signs of cancer are found in the tissue samples after treatment.

The purpose of the study is to compare the effectiveness of standard treatments with T-DXd in patients with HER2-positive breast cancer. Participants will receive either the standard treatment or T-DXd. The study will monitor the response to these treatments, focusing on how well the cancer responds and whether it disappears completely in the treated area. The study will also look at the overall health and survival of the participants over time.

Participants in the study will receive their assigned treatment and will be monitored regularly by healthcare professionals. The study will track the progress of the cancer and any side effects from the treatments. The goal is to determine which treatment is more effective in treating HER2-positive breast cancer and to gather information that could help improve future treatment options for this type of cancer.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history, a physical examination, and various tests to ensure you meet the study criteria.

You will be asked to provide blood and tumor samples for analysis. These samples help in understanding your specific condition and tailoring the treatment accordingly.

2 randomization

After the initial assessment, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the standard therapy or the new treatment being tested.

3 treatment phase

If you are assigned to the standard therapy group, you will receive a combination of medications including trastuzumab, pertuzumab, docetaxel, and carboplatin. These medications are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.

If you are assigned to the new treatment group, you will receive trastuzumab deruxtecan as a monotherapy. This medication is also administered through an intravenous infusion.

The treatment phase will last for several cycles, with each cycle typically lasting three weeks. The exact number of cycles will depend on your response to the treatment and the specific protocol of the study.

4 monitoring and follow-up

Throughout the treatment phase, you will have regular appointments to monitor your health and the effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies such as mammograms or MRIs.

You will be asked to report any side effects or changes in your health. This information is crucial for ensuring your safety and adjusting the treatment if necessary.

5 surgery and evaluation

After completing the treatment cycles, you will undergo surgery to remove any remaining cancerous tissue. The type of surgery will depend on the size and location of the tumor and your overall health.

A pathologist will examine the surgical specimen to assess the response to the treatment. This evaluation helps determine the effectiveness of the therapy and guides any further treatment decisions.

6 long-term follow-up

Following surgery, you will continue to have regular follow-up visits to monitor your recovery and check for any signs of cancer recurrence.

These visits may include physical exams, imaging tests, and discussions about your overall health and any ongoing symptoms or concerns.

Who Can Join the Study?

Women or men who are 18 years or older.
Women who can have children must have a negative pregnancy test.
Women who can have children must agree to use one highly effective birth control method or two effective nonhormonal birth control methods.
Participants must be able to communicate with the study doctor and follow the study procedures.
Participants must provide written consent to join the study, following international and local guidelines.
Participants must have breast cancer confirmed by a test, with a tumor size of at least 20 mm or cancer spread to nearby lymph nodes.
Participants must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Participants must know their estrogen-receptor and/or progesterone receptor status, which are tests to see if hormones affect the cancer. At least 10% of cells must show these receptors for the study.
Participants must have HER2-positive breast cancer, which means the cancer has high levels of a protein called HER2.
Participants must have a Left Ventricular Ejection Fraction (LVEF) of at least 50%, which is a measure of how well the heart pumps blood.
Participants must have adequate bone marrow, liver, and kidney function.
Tumor and blood samples must be available as described in the study protocol.

Who Cannot Join the Study?

Patients with any other type of cancer that has spread to other parts of the body (metastatic cancer) cannot participate.
Patients who have previously been treated with the study drug, trastuzumab deruxtecan (T-DXd), are not eligible.
Patients with severe heart problems, such as heart failure, are excluded.
Patients with uncontrolled high blood pressure cannot take part in the study.
Patients with active infections that require treatment with antibiotics are not eligible.
Pregnant or breastfeeding women cannot participate in the study.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients who are currently participating in another clinical trial are not eligible.
Patients with any other serious medical condition that might interfere with the study are excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Institut Jules Bordet	Anderlecht	Belgium
Karolinska University Hospital	Solna	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Nordlandssykehuset HF	Bodo	Norway
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Norrlands University Hospital	Umea	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Sankt Gorans Sjukhus	Stockholm	Sweden
Vestre Viken HF	Drammen	Norway
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Gasthuiszusters Antwerpen	Antwerp	Belgium
Malarsjukhuset Eskilstuna	Eskilstuna	Sweden
Region Kronoberg	Vaxjo	Sweden
Region Oerebro Laen	Orebro	Sweden
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Udhrkbg Umntratnrr Hjiikope	Uppsala	Sweden
Hyvno Mkzfv Ot Rxwnygz Hu	Aalesund	Norway

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.05.2023
Norway	Recruiting	01.05.2023
Sweden	Recruiting	01.05.2023

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan is a medication used in this trial to treat a specific type of breast cancer known as HER2-positive breast cancer. This medication works by targeting and attaching to the HER2 protein, which is found in high amounts on some cancer cells. Once attached, it delivers a powerful anti-cancer drug directly into the cancer cell, helping to kill the cancer cells and stop them from growing. This targeted approach aims to improve treatment outcomes by focusing on the cancer cells while minimizing damage to healthy cells.

Investigated diseases:

HER2 positive breast cancer

Non-metastatic HER2-positive Breast Cancer – This type of breast cancer is characterized by the overexpression of the Human Epidermal Growth Factor Receptor 2 (HER2) protein, which promotes the growth of cancer cells. It is classified as non-metastatic, meaning it has not spread beyond the breast or nearby lymph nodes. The disease progresses as cancer cells grow and multiply, potentially forming a tumor in the breast tissue. Over time, if untreated, it may invade surrounding tissues or spread to other parts of the body. The progression can vary depending on the molecular characteristics of the cancer and the patient’s individual biology. Early detection and intervention are crucial in managing the disease’s progression.

Trial ID:

2022-501504-95-00

Protocol code:

ARIADNE

NCT ID:

NCT05900206

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Trastuzumab Deruxtecan with Standard Treatment for Patients with HER2-positive Breast Cancer

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