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Study on the Effectiveness of Trastuzumab Deruxtecan in Patients with HER2-Positive Oligometastatic Breast Cancer

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What is this trial about?

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

This clinical trial is focused on studying a specific type of breast cancer known as HER2-positive oligometastatic breast cancer. This type of cancer is characterized by the presence of a limited number of cancerous lesions that have spread to other parts of the body. The treatment being tested in this study is called trastuzumab deruxtecan, also known by its code name DS-8201a. This medication is administered as a solution through an intravenous infusion, which means it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective trastuzumab deruxtecan is when used as part of a combination treatment approach for patients with HER2-positive oligometastatic breast cancer. Participants in the study will receive the medication and will be monitored over a period of time to assess the treatment's impact on their cancer. The study will also involve regular imaging tests, such as MRI and PET-CT, to track changes in the cancer and determine the treatment's effectiveness.

Throughout the study, researchers will be looking for a complete response to the treatment, which means that the cancer is no longer detectable on imaging tests. They will also monitor for any side effects that participants may experience. The study aims to provide valuable information on the potential benefits of trastuzumab deruxtecan for patients with this specific type of breast cancer.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of HER2-positive breast cancer with limited metastases.

    Initial assessments include imaging tests such as PET-CT and MRI to evaluate the extent of the disease.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of trastuzumab deruxtecan, also known as DS-8201a.

    This medication is given as a solution for infusion through an intravenous line.

    The frequency and dosage are determined by the study protocol and are administered under medical supervision.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment, including imaging tests to track changes in the cancer.

    The primary goal is to achieve a complete radiologic response, as defined by specific criteria.

  4. Step 4

    Additional treatments

    Depending on the response, additional treatments may be planned, such as surgery or radiation, to target remaining cancer cells.

    These treatments are scheduled to avoid delays and are part of the comprehensive care plan.

  5. Step 5

    Follow-up and evaluation

    After completing the treatment phase, follow-up evaluations are conducted to monitor for any adverse effects and to ensure the cancer remains under control.

    The study aims to track the long-term outcomes and any potential side effects until 30 days after the last treatment.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of HER2-positive breast cancer. This means the cancer cells have a protein called HER2 on their surface, which can be identified through specific tests.
  • Must have proof of breast cancer that has spread to other parts of the body, known as metastases. At least one area of spread must be confirmed.
  • Must have a test to determine the level of ER-expression, which refers to the presence of estrogen receptors on the cancer cells.
  • Must have oligo-metastatic disease, meaning the cancer has spread to a limited number of areas, specifically up to three separate spots. These can be in one organ or spread across 2-3 different organ systems. Certain types of spread, like widespread small spots or spread in the lining of the abdomen, are not allowed.
  • If the cancer has come back after treatment, there must have been a period of at least 24 months without the disease.
  • Must have cancer that can be measured according to specific guidelines called RECIST1.1.
  • Must be at least 18 years old, able to understand the study, and agree to participate by signing a consent form.
  • Must have a World Health Organization (WHO) performance status of 0 or 1, which means the person is fully active or has some symptoms but can still carry out light work.

Who cannot join the trial?

5 criteria

  • Patients who do not have HER2-positive breast cancer. HER2-positive means that the cancer cells have more of a protein called HER2, which can make the cancer grow faster.
  • Patients who do not have oligometastatic disease. Oligometastatic disease means that the cancer has spread to a few other parts of the body, but not many.
  • Patients who are not within the specified age range for the study.
  • Patients who are not eligible based on gender requirements for the study.
  • Patients who belong to a vulnerable population that is not selected for this study.
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Investigated drugs

T-DXd is a medication being studied for its effectiveness in treating patients with HER2-positive oligo-metastatic breast cancer. It is part of a multi-modality treatment approach, which means it is used alongside other treatments to see how well it works in managing this type of cancer.

What is already known about the treatment

T-DXd – T-DXd is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating HER2-positive breast cancer with limited metastasis. The main therapeutic indication for T-DXd is breast cancer, specifically in cases where the cancer is HER2-positive and has spread to a few other parts of the body. At the molecular level, T-DXd works by delivering a chemotherapy drug directly to cancer cells, targeting the HER2 protein, which is often overexpressed in certain types of breast cancer. It is classified pharmacologically as an antibody-drug conjugate, combining targeted therapy with chemotherapy.

Investigated diseases

Breast Cancer, HER2-Positive, Oligometastatic Disease – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. In the oligometastatic stage, the cancer has spread beyond the breast to a limited number of other sites in the body. The progression of this disease involves the growth and potential spread of cancerous cells, which can affect various organs. HER2-positive cancers tend to grow and spread more aggressively than other types of breast cancer. The disease's behavior can vary, with some cases remaining stable for a period while others may progress more rapidly. Understanding the specific characteristics of the cancer, such as its HER2 status, is crucial in determining its progression and potential impact on the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505039-11-00Estimated enrolment112 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).