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Study of trastuzumab deruxtecan treatment in patients with advanced HER2-positive breast cancer with or without 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 study focuses on patients with HER2-positive breast cancer that has spread to other parts of the body (advanced or metastatic), including those who may or may not have cancer that has spread to the brain (brain metastasis). The study will use a medicine called trastuzumab deruxtecan (also known as DS-8201a), which is given through an intravenous infusion directly into a vein.

The purpose of this research is to understand how well trastuzumab deruxtecan works in treating advanced breast cancer patients, particularly looking at its effects in patients whose cancer has spread to the brain and those whose cancer has not. The medicine will be given to patients who have already received previous treatments for their breast cancer.

During the study, participants will receive regular doses of trastuzumab deruxtecan through infusions. Doctors will monitor how the cancer responds to treatment and track any changes in both the body and, if present, in the brain. The study will also look at how the treatment affects patients' daily lives and overall well-being, including any side effects that may occur during treatment.

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

    Initial assessment

    Your eligibility for the study will be evaluated based on your breast cancer diagnosis, which must be advanced or metastatic and HER2-positive.

    A brain scan (MRI or CT) will be performed to check for the presence of brain metastases.

  2. Step 2

    Group assignment

    Based on the brain scan results, you will be assigned to one of two groups:

    Group 1: Patients without brain metastases

    Group 2: Patients with brain metastases

  3. Step 3

    Treatment administration

    You will receive trastuzumab deruxtecan (DS-8201a) through an intravenous infusion.

    The medication will be given as a solution directly into your vein.

    Treatment will continue until specific medical criteria are met

  4. Step 4

    Monitoring and assessments

    Regular medical examinations will track your response to treatment

    Brain scans will be performed to monitor any changes

    Your symptoms and overall well-being will be evaluated using questionnaires

    Regular checks of vital signs, laboratory tests, and heart activity (ECG) will be conducted

  5. Step 5

    Follow-up period

    Your health status will continue to be monitored after completing the treatment

    The study is expected to continue until February 2026

Who can join the trial?

12 criteria

  • Must have confirmed breast cancer that is either advanced or has spread to other parts of the body (metastatic), and cannot be removed by surgery
  • Must have HER2-positive breast cancer (a specific type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2)
  • Must fall into one of these brain-related categories:
    • No brain metastases (cancer has not spread to the brain)
    • Untreated brain metastases that don't need immediate treatment
    • Previously treated brain metastases that are either stable or growing
    • If brain metastases are present, patients must:
      • Be neurologically stable
      • Take no more than 3 mg per day of dexamethasone (if needed)
      • Be on a stable seizure medication dose for at least 14 days (if taking any)
      • Previous cancer treatment history must include:
        • Evidence that cancer has grown while on HER2-targeted therapy or within 6 months after completing treatment
        • No more than 2 previous treatment regimens for metastatic cancer
        • Both men and women may participate
        • Must be an adult (18 years or older)

Who cannot join the trial?

12 criteria

  • History of severe allergic reactions to previous cancer treatments
  • Active or untreated brain metastases (cancer that has spread to the brain) requiring immediate treatment
  • Heart conditions including heart failure, irregular heartbeat, or recent heart attack within the last 6 months
  • Current treatment with other experimental drugs or participation in other clinical trials
  • Impaired liver or kidney function that could affect the metabolism of the study medication
  • Active infections requiring systemic treatment (medications that affect the whole body)
  • Previous treatment with similar HER2-targeted therapies that resulted in serious side effects
  • Pregnancy or breastfeeding
  • Any other serious medical condition that could make participation unsafe
  • Unable to follow study procedures or attend scheduled visits
  • Blood disorders that could increase the risk of complications
  • History of other cancers within the past 5 years (except for successfully treated skin cancer or cervical cancer)
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Investigated drugs

Trastuzumab Deruxtecan (T-DXd) is an antibody-drug conjugate medication used to treat breast cancer. It specifically targets cancer cells that have high levels of a protein called HER2. The medication works by combining a targeted antibody (which finds and attaches to cancer cells) with a chemotherapy drug (which helps destroy the cancer cells). This medication is particularly important for treating advanced or metastatic breast cancer that has spread to other parts of the body, including cases where cancer may have spread to the brain.

What is already known about the treatment

Trastuzumab Deruxtecan (T-DXd) - An advanced antibody-drug conjugate administered via intravenous infusion, specifically designed for treating HER2-positive breast cancer, including cases with brain metastases. This medication combines a HER2-targeted antibody with a potent chemotherapy drug, working by precisely delivering the cancer-fighting agent to tumor cells that express HER2 protein while minimizing damage to healthy tissues. Currently approved and actively used in clinical practice, it represents a significant advancement in targeted breast cancer therapy, particularly for patients whose disease has progressed after previous treatments.

Investigated diseases

  • HER2-positive breast cancer

    A type of breast cancer that develops when breast cells have too many copies of the HER2 gene, making excess HER2 proteins that promote cancer cell growth. This form of breast cancer tends to grow and spread more aggressively than other types. The cancer begins in the breast tissue and can affect various parts of the breast. As the disease progresses, cancer cells may spread to other parts of the body, including the brain (brain metastasis). Brain metastasis occurs when cancer cells from the breast travel through the bloodstream or lymphatic system and form new tumors in the brain.

  • Brain metastasis

    A condition that occurs when cancer cells spread from their original location to the brain, forming secondary tumors. In breast cancer patients, these metastases develop when cancer cells break away from the primary breast tumor and travel through the bloodstream or lymphatic system to the brain. The metastatic tumors can form in various parts of the brain and may be single or multiple. These secondary tumors grow in the brain tissue and can affect normal brain function.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510588-53-00Protocol codeD9673C00007Estimated enrolment587 patientsSponsorAstraZeneca AB

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