A study of Zr89-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. 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.

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 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 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 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 Study?

  • 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 Study?

  • 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

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 Status
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
Ukjtnzpzhi Og Ahwvjgf Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.01.2025

Trial locations

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.

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 ID:
2024-516253-49-00
Protocol code:
IJB-ZEPHIR02-2024
NCT ID:
NCT06595563
Trial Phase:
Therapeutic exploratory (Phase II)

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