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A study of Zr89-trastuzumab PET/CT imaging and trastuzumab emtansine treatment in patients with advanced HER2-positive 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 advanced HER2-positive breast cancer. The research examines how well imaging with 89Zr-trastuzumab PET/CT (a special type of scan that shows detailed pictures of cancer cells) can help predict which treatments might work best. This type of breast cancer has high levels of a protein called HER2 on the surface of cancer cells.

The study uses several medications that target HER2-positive breast cancer. The main treatment being studied is trastuzumab emtansine (also known as T-DM1), which is given through an infusion into a vein. This medication combines two parts - one that targets cancer cells and another that helps destroy them. Another medication used in the study is Herceptin, which is also given through an infusion.

The purpose is to understand how cancer cells change after previous treatments and to see how well T-DM1 works in patients whose special scans show certain results. The study involves getting scans, blood tests, and tissue samples to examine the cancer in detail. Patients will receive treatment and be monitored to see how their cancer responds to the medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    You will undergo screening tests to confirm eligibility, including blood tests to check liver function, bone marrow function, and kidney function

    A heart test will be performed to check your left ventricular ejection fraction (heart pumping ability) must be at least 50%

    An imaging scan called FDG-PET will be performed to identify at least two target lesions for monitoring

  2. Step 2

    Baseline imaging

    You will receive an injection of 89Zr-trastuzumab (a radioactive form of trastuzumab) through an intravenous line

    A PET/CT scan will be performed to create detailed images of your cancer

  3. Step 3

    Treatment phase

    If your scan results are positive, you will receive T-DM1 (trastuzumab emtansine) through intravenous infusion

    Regular monitoring will occur to assess your response to treatment

    Treatment will continue until disease progression, unacceptable side effects, or other reasons for discontinuation

  4. Step 4

    Monitoring and follow-up

    Regular assessments will track your response to treatment using imaging scans

    Blood tests will monitor your body functions

    Side effects will be tracked and documented throughout the treatment period

    Your overall survival will be monitored from the start of treatment

Who can join the trial?

19 criteria

  • Must be 18 years or older
  • Must have adequate liver function, including:
    • Normal bilirubin levels (or diagnosed Gilbert syndrome)
    • Liver enzymes (AST and ALT) within acceptable limits
    • Must have good heart function:
      • Heart pumping capacity (LVEF) of at least 50%
      • No history of severe heart problems
      • Must agree to provide tissue samples (through biopsy) and blood samples
      • Must be willing to follow study protocol, including all visits and examinations
      • Must sign informed consent form before starting any study procedures
      • Must have good physical ability (ECOG score of 0 or 1, meaning able to perform daily activities)
      • Must have confirmed HER2-positive breast cancer that has spread to other parts of the body
      • Must have previously received treatment with:
        • Taxane (a type of chemotherapy)
        • Trastuzumab and pertuzumab (targeted therapies)
        • T-DXd as the most recent treatment, with disease progression during this treatment
        • Must have a life expectancy of at least 6 months
        • Must have at least two tumors visible on PET scan that meet specific size and activity criteria
        • Must have adequate bone marrow function, including:
          • Acceptable white blood cell counts
          • Adequate platelet levels
          • Sufficient hemoglobin levels
          • Must have adequate kidney function based on blood tests

Who cannot join the trial?

12 criteria

  • Previous treatment with T-DM1 (a targeted therapy drug for breast cancer)
  • Active brain metastases (cancer that has spread to the brain) that are not stable or require treatment
  • Significant heart problems including:
    • Heart failure
    • Irregular heartbeat that is not controlled
    • Recent heart attack (within 6 months)
    • Severe liver problems or abnormal liver function tests
    • Pregnant or breastfeeding women
    • Known allergic reactions to any of the study medications
    • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Any serious medical condition that could interfere with study participation
    • Unable to undergo required imaging procedures
    • Current participation in another clinical trial with investigational drugs
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Investigated drugs

Based on the trial information provided, here are the medications involved: Trastuzumab (labeled with Zirconium-89) is an antibody medication used for imaging purposes. It specifically targets HER2-positive breast cancer cells and helps doctors see where cancer cells are located in the body using a special type of scan called PET/CT. T-DM1 (also known as Trastuzumab emtansine) is an antibody-drug conjugate medication used to treat HER2-positive breast cancer. It combines trastuzumab with a chemotherapy drug, allowing it to directly target and kill cancer cells that have high levels of HER2 protein on their surface.

What is already known about the treatment

  • Trastuzumab

    An intravenously administered monoclonal antibody specifically designed to target HER2-positive breast cancer cells. This medication is widely used in modern oncology for treating advanced and metastatic HER2-positive breast cancer, working by attaching to HER2 proteins on cancer cells and blocking their growth signals. As a targeted therapy, it belongs to the class of biological response modifiers and has shown significant effectiveness in clinical practice when combined with other treatments.

  • T-DM1 (Trastuzumab emtansine)

    An antibody-drug conjugate administered intravenously that combines trastuzumab with a chemotherapy agent DM1. This medication is specifically approved for treating HER2-positive metastatic breast cancer in patients who previously received trastuzumab and a taxane chemotherapy. It works by delivering the chemotherapy directly to cancer cells that express HER2, minimizing damage to healthy cells and belongs to the targeted therapy class of cancer medications.

  • Zirconium-89 (89Zr) labeled trastuzumab

    A diagnostic imaging agent administered intravenously that combines trastuzumab with a radioactive isotope for PET/CT imaging. This specialized form of trastuzumab is used to visualize and measure HER2 expression in breast cancer tumors, helping doctors to assess treatment response and plan further therapy. It belongs to the class of diagnostic radiopharmaceuticals and represents an advanced approach in molecular imaging.

Investigated diseases

HER2-Positive Breast Cancer - A type of breast cancer that occurs when cancer cells have too much of a protein called HER2 on their surface. This form of breast cancer tends to grow and spread more aggressively than other types. The disease begins in the breast tissue and can develop into an advanced or metastatic form, meaning it spreads to other parts of the body. In metastatic cases, cancer cells typically spread through the bloodstream or lymphatic system to form tumors in other organs. The presence of excess HER2 proteins makes these cancer cells particularly active in terms of growth and division. The disease progression can vary from person to person, with some experiencing faster growth rates than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516253-49-00Protocol codeIJB-ZEPHIR02-2024Estimated enrolment31 patientsSponsorInstitut Jules Bordet

sourced from the EU Clinical Trials Register and site verification

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