Study of 89Zr-trastuzumab PET/CT imaging and trastuzumab emtansine treatment in patients with advanced HER2-positive breast cancer

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
HUmani	Charleroi	Belgium
Agoxihfbt Uhe	Amsterdam	The Netherlands
Uxxyfiwfqeyd Motgutd Clxwjar Gbzsjvski	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2025
The Netherlands	Not yet recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

HER2 positive breast cancer

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 ID:

2024-516253-49-01

Protocol code:

IJB-ZEPHIR02-2024

NCT ID:

NCT06595563

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of 89Zr-trastuzumab PET/CT imaging and trastuzumab emtansine treatment in patients with advanced HER2-positive breast cancer

What is this study about?

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