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Study of Trastuzumab Deruxtecan for Patients with HER2-Low Breast Cancer and New or Worsening Brain Metastases

Verified siteInvestigationalNo placebo
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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 type of breast cancer known as HER2-low breast cancer, which has spread to the brain, a condition referred to as brain metastases. The study is investigating the effects of a treatment called Trastuzumab Deruxtecan, also known by its code name DS-8201a. This treatment is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective this treatment is for patients with HER2-low breast cancer that has either been newly diagnosed or is progressing in the brain. Participants in the study will receive the treatment and be monitored over time to see how their cancer responds. The study will also include a comparison with a placebo to better understand the treatment's effects. The trial will last for a period of time, during which participants will have regular check-ups and assessments to track their progress and any changes in their condition.

Throughout the study, the focus will be on understanding the treatment's impact on the cancer in the brain, as well as any side effects or changes in the participants' quality of life. The study aims to provide valuable information that could help improve treatment options for patients with this specific type of breast cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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, the patient must have signed a written informed consent form. This indicates understanding of the study's purpose.

    The patient must have completed at least one line of systemic treatment for advanced breast cancer.

  2. Step 2

    Pre-treatment assessment

    A washout period is required before starting the study treatment. This includes a minimum of four weeks after local therapy or antibody treatment, and three weeks after chemotherapy or other targeted treatments.

    The patient must undergo tests to confirm adequate heart function, bone marrow, liver, and kidney health. This includes a left ventricular ejection fraction of at least 50% and specific blood test results.

  3. Step 3

    Treatment initiation

    The patient will receive the study medication, trastuzumab deruxtecan (also known as DS-8201a), administered as a solution for infusion through an intravenous route.

    The treatment schedule and dosage will be determined by the study protocol and the patient's specific condition.

  4. Step 4

    Ongoing treatment and monitoring

    The patient will continue to receive the study medication at regular intervals as specified in the study protocol.

    Regular monitoring will be conducted to assess the patient's response to the treatment and to manage any side effects. This includes imaging studies and clinical evaluations.

  5. Step 5

    Completion of treatment

    The treatment will continue until the study's end date or until the patient experiences disease progression or unacceptable side effects.

    The study is estimated to conclude by June 2026.

Who can join the trial?

18 criteria

  • The patient must understand the purpose of the study and sign a written consent form before starting any study procedures.
  • The patient must have received at least one line of treatment for advanced cancer.
  • The patient must have a break from certain treatments before joining the study: at least 4 weeks for local therapy or antibody treatment, and at least 3 weeks for other cancer treatments.
  • The patient must have a heart function test showing a left ventricular ejection fraction (LVEF) of 50% or higher.
  • The patient must have good bone marrow, liver, kidney, and blood clotting function. This includes specific blood test results that meet certain criteria.
  • The patient must have recovered from any side effects of previous cancer treatments to a mild level, except for hair loss or other non-risky side effects.
  • Women who can have children must agree to use effective birth control during the study and for 7 months after the last treatment. They must also have a negative pregnancy test before starting the study and agree not to donate eggs during this time.
  • Men must agree to use birth control or abstain from sex during the study and for 4 months after the last treatment. They must also agree not to donate sperm during this time.
  • The patient must be able to handle the treatment.
  • The patient must be available for treatment and follow-up visits.
  • The patient must be 18 years or older at the time of signing the consent form.
  • The patient must have breast cancer that has spread, with a specific HER2-low status confirmed by guidelines.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have a performance status score indicating they can perform daily activities with some help.
  • The patient must not have any reasons that prevent them from receiving T-DXd therapy.
  • The patient must have newly diagnosed or worsening brain metastases that do not need immediate local treatment.
  • The patient must have measurable disease according to specific criteria for brain metastases.
  • The patient must have at least one brain lesion that is measurable or may have untreated type II leptomeningeal disease.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer that are not **HER2-low breast cancer**.
  • Patients who do not have **brain metastases**, which means cancer that has spread to the brain.
  • Patients who have not been newly diagnosed or do not have progressing brain metastases.
  • Patients with a type of cancer spread called **type II leptomeningeal disease** that is not associated with HER2-low breast cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they may need special protection or care.
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Investigated drugs

Trastuzumab-Deruxtecan (T-DXd; DS-8201a) is a medication being studied for its effectiveness in treating patients with HER2-low breast cancer who have newly diagnosed or progressing brain metastases. This medication is designed to target and bind to the HER2 protein on cancer cells, delivering a chemotherapy drug directly to the cancer cells to help destroy them. The goal of this study is to evaluate how well this medication works in reducing the size or number of brain metastases in these patients.

What is already known about the treatment

Trastuzumab-Deruxtecan – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating HER2-low breast cancer, particularly in patients with brain metastases. The main therapeutic indication is for breast cancer that has spread to the brain. At the molecular level, it works by targeting the HER2 protein on cancer cells, delivering a chemotherapy agent directly to these cells to kill them. It is classified as an antibody-drug conjugate, combining a targeted therapy with chemotherapy.

Investigated diseases

HER2-low breast cancer with brain metastases – This type of breast cancer is characterized by low levels of the HER2 protein on the surface of cancer cells. It can spread to the brain, forming secondary tumors known as brain metastases. The disease may also involve type II leptomeningeal disease, where cancer cells spread to the membranes surrounding the brain and spinal cord. As the cancer progresses, it can lead to neurological symptoms due to the growth of tumors in the brain. The progression of the disease can vary, with some patients experiencing rapid changes while others may have a slower course. The presence of brain metastases often complicates the disease, affecting the patient's quality of life and neurological function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506702-39-00Protocol codeMEDOPP596Estimated enrolment27 patientsSponsorMedica Scientia Innovation Research S.L.

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