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Study of 89Zr-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 who have previously received treatment. The research aims to examine how well imaging with 89Zr-trastuzumab PET/CT can help predict which patients will respond best to future treatments. This special imaging technique allows doctors to see how the cancer cells interact with specific medications.

The study involves several medications that target HER2-positive breast cancer. Patients will receive trastuzumab emtansine (also known as T-DM1) as treatment. Before starting treatment, patients will undergo imaging with a specially modified version of trastuzumab that has been labeled with a radioactive substance to help create detailed images of the cancer. This imaging helps doctors understand how the cancer might respond to treatment.

During the study, patients will receive regular medical check-ups to monitor their response to treatment. The research team will track how long the treatment remains effective and watch for any side effects. They will also collect tissue and blood samples to study how the cancer cells change over time. This information will help doctors better understand which patients are most likely to benefit from specific treatments.

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 assessment

    Your eligibility for the trial will be confirmed through medical tests and examinations

    Key requirements include being at least 18 years old, having an ECOG performance status of 1 or less (able to carry out light work), and having confirmed HER2-positive breast cancer that has spread

    Medical tests will check your heart function (must be 50% or higher), liver function, kidney function, and blood cell counts

    You must have previously received treatment with specific medications including taxane, trastuzumab, pertuzumab, and T-DXd

  2. Step 2

    Imaging procedures

    You will undergo two types of imaging scans:

    An FDG-PET scan to identify suitable target lesions for monitoring

    A HER2-PET/CT scan using a special tracer called 89Zr-trastuzumab to examine HER2 expression in your cancer

  3. Step 3

    Treatment phase

    If your HER2-PET/CT scan results are positive, you will receive treatment with T-DM1 (trastuzumab emtansine)

    The medication will be given through an intravenous infusion

    Regular assessments will monitor your response to treatment and any side effects

    Treatment will continue until disease progression or unacceptable side effects occur

  4. Step 4

    Monitoring and follow-up

    Regular medical examinations and scans will track your response to treatment

    Side effects will be monitored and recorded throughout the study

    Blood samples and tumor tissue samples will be collected for research purposes

    Your overall survival and duration of response to treatment will be tracked

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Must have proper liver function, including: - Normal bilirubin levels (unless diagnosed with Gilbert syndrome) - Liver enzymes (AST and ALT) within acceptable limits
  • Must have good heart function, with: - Heart pumping capacity (LVEF) of 50% or higher - No history of severe heart problems or recent heart attack
  • Must agree to provide tissue samples (through biopsy) and blood samples
  • Must be willing to follow study requirements, including all treatments and scheduled visits
  • Must sign an informed consent form before starting any study procedures
  • Must have good physical condition (ECOG status 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 specific cancer medications (taxane, trastuzumab, pertuzumab, and T-DXd)
  • Must have a life expectancy of at least 6 months
  • Must have at least two tumors that can be measured by special imaging (FDG-PET scan)
  • Must have adequate bone marrow function, showing: - Sufficient white blood cells - Sufficient platelets - Sufficient hemoglobin levels
  • Must have proper kidney function with normal creatinine levels or good creatinine clearance

Who cannot join the trial?

11 criteria

  • History of allergic reactions or severe side effects to trastuzumab emtansine (T-DM1) or similar medications
  • Current participation in other clinical trials or use of investigational drugs within 30 days before starting this study
  • Presence of brain metastases (cancer spread to the brain) that are not stable or require ongoing treatment
  • Severe heart conditions, including heart failure or uncontrolled high blood pressure
  • Significant liver problems or abnormal liver function tests
  • Active or untreated infections, including hepatitis B, hepatitis C, or HIV
  • Major surgery within 4 weeks before starting the study
  • Pregnant or breastfeeding women
  • Unable to undergo PET/CT scanning (a type of medical imaging that shows both body structure and function)
  • History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ (early-stage)
  • Any medical condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

  • Trastuzumab

    is a targeted therapy medication used to treat HER2-positive breast cancer. It works by attaching to HER2 proteins on cancer cells, helping to stop them from growing and spreading.

  • Zirconium-89 labeled trastuzumab

    (89Zr-trastuzumab) is a special form of trastuzumab that has been tagged with a radioactive marker. It is used in PET/CT imaging to see how well HER2-targeted treatments might work for a patient by showing where HER2-positive cancer cells are located in the body.

  • T-DM1

    (Trastuzumab emtansine) is an antibody-drug conjugate that combines trastuzumab with a chemotherapy drug. It works by delivering the chemotherapy directly to HER2-positive cancer cells, potentially causing fewer side effects than traditional chemotherapy.

What is already known about the treatment

  • Trastuzumab (89Zr-labeled)

    A specialized diagnostic imaging agent administered intravenously for PET/CT scanning, specifically designed to detect HER2-positive breast cancer cells. This radioactive-labeled version of trastuzumab binds to HER2 receptors on cancer cells, allowing doctors to visualize the distribution and expression levels of HER2 throughout the body. The medication belongs to the class of diagnostic radiopharmaceuticals and helps clinicians determine the effectiveness of HER2-targeted therapies and guide treatment decisions.

  • T-DM1 (Trastuzumab emtansine)

    An antibody-drug conjugate administered via intravenous infusion, combining trastuzumab with a powerful chemotherapy agent DM1. This targeted therapy is specifically used for treating advanced HER2-positive breast cancer in patients who have received prior treatments. The medication works by delivering the chemotherapy directly to HER2-positive cancer cells, while minimizing exposure to healthy tissues, and belongs to the class of targeted anti-cancer agents.

Investigated diseases

HER2-Positive Breast Cancer - A form of breast cancer characterized by excessive amounts of HER2 protein on the surface of cancer cells. This type of breast cancer occurs when breast cells begin to grow abnormally and produce too much of a protein called HER2 (Human Epidermal Growth Factor Receptor 2). The cancer typically starts in the breast tissue and can spread to other parts of the body through the lymphatic system or bloodstream. In advanced or metastatic stages, the cancer cells have spread beyond the breast to other organs. This cancer tends to be more aggressive than HER2-negative breast cancers, with cancer cells dividing and growing more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516253-49-01Protocol codeIJB-ZEPHIR02-2024Estimated enrolment109 patientsSponsorInstitut Jules Bordet

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