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Study on Imaging and Treatment Prediction for Metastatic Breast Cancer Using Gallium (68Ga) Tezatabep Matraxetan and Trastuzumab Deruxtecan

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 clinical trial is focused on studying metastatic breast cancer, which is a type of breast cancer that has spread to other parts of the body. The study will use a special imaging technique called PET-imaging with a substance known as 68Ga-ABY-025 to look at the levels of a protein called HER2 in the cancer. HER2 is a protein that can affect how breast cancer grows and responds to treatment. The purpose of the study is to see if this imaging can help predict how well patients will respond to a treatment called trastuzumab deruxtecan, also known by its code name DS-8201 or Enhertu.

Participants in the study will receive the imaging agent 68Ga-ABY-025 through an injection, and then undergo a PET scan to visualize the HER2 expression in their cancer. After this, they will receive the treatment trastuzumab deruxtecan, which is given as an infusion. The study will monitor changes in the cancer and assess the treatment's effectiveness over time. The goal is to understand if the initial imaging can help predict which patients will benefit most from the treatment.

This study is important because it could lead to better ways to tailor treatments for patients with HER2-positive metastatic breast cancer, potentially improving outcomes by identifying those who are most likely to benefit from specific therapies. The study will also look at how the treatment affects patients' quality of life and overall survival. Participants will be followed for a period to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A biopsy may be required if a recent one is not available. This involves taking a small sample of tissue from a metastatic lesion for analysis.

  2. Step 2

    Baseline imaging

    A PET scan using [68Ga]Ga-ABY-025 is performed to assess HER2 expression in the cancer. This scan helps in understanding the characteristics of the cancer and planning treatment.

  3. Step 3

    Treatment initiation

    Treatment with trastuzumab deruxtecan (T-DXd) begins. This medication is administered as an infusion, which means it is given directly into the bloodstream through a vein.

    The dosage and frequency of the infusion are determined by the study protocol and the healthcare team.

  4. Step 4

    Treatment cycles

    The treatment is given in cycles. Each cycle consists of a period of treatment followed by a period of rest to allow the body to recover.

    After two cycles of treatment, another PET scan is performed to evaluate the response of the cancer to the treatment.

  5. Step 5

    Ongoing evaluation

    Throughout the study, regular assessments are conducted to monitor health and response to treatment. This includes imaging tests, blood tests, and questionnaires about quality of life.

    Adjustments to the treatment plan may be made based on these evaluations.

  6. Step 6

    Study completion

    The study is expected to continue until December 2032. Participation may end earlier if the treatment is no longer beneficial or if there are significant side effects.

    Upon completion, a final assessment is conducted to gather data on the overall impact of the treatment.

Who can join the trial?

8 criteria

  • The patient must be a female who is at least 18 years old.
  • The patient must have metastatic (cancer that has spread to other parts of the body) or locally advanced breast cancer (cancer that has spread to nearby tissues) that has gotten worse after at least one round of chemotherapy in a palliative setting, or the cancer has come back within six months after finishing chemotherapy given before or after surgery.
  • The patient must be able and willing to provide written consent to participate in the study.
  • The patient must have at least one metastatic lesion (an area where cancer has spread) that is at least 10 mm in size available for a biopsy. A biopsy is a procedure where a small piece of tissue is taken for testing. An exception can be made if a recent biopsy is available (no more than three months old) and the patient has not received any cancer treatment or local radiation therapy to that specific area.
  • The patient must have at least one additional metastatic index lesion (a specific area of cancer spread) that is at least 10 mm in size for evaluating the effect of the treatment. This is according to a standard called RECIST v1.1, which is a set of rules used to measure how well a cancer treatment is working.
  • The patient must have a WHO performance status of 2 or less. This is a scale used to measure how well a patient can perform ordinary tasks and carry out daily activities.
  • The patient must have an expected survival of more than 12 weeks.
  • If the patient is of child-bearing potential, she must agree to use effective contraception (methods to prevent pregnancy) before entering the study, during the study treatment phase, and for six months after the last dose of the study drug. Effective methods include procedures like bilateral tubal ligation (surgical procedure to block the fallopian tubes), male sterilization (vasectomy), proper use of hormonal contraceptives that stop ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Methods like periodic abstinence and withdrawal are not acceptable. Women must also refrain from donating eggs during this period. If a woman becomes pregnant or thinks she might be pregnant while in the study, she should inform her study doctor immediately. If a female participant is of child-bearing potential, she must have a documented negative serum pregnancy test before receiving the study drug.

Who cannot join the trial?

4 criteria

  • Patients who do not have **breast cancer** cannot participate. **Breast cancer** is a type of cancer that starts in the breast.
  • Only **female** patients are allowed to participate. Male patients cannot join the study.
  • Patients who are not in the specified **age range** cannot participate. The study is for certain age groups only.
  • Patients who are part of a **vulnerable population** cannot participate. This means people who might need special protection or care.
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Investigated drugs

T-DXd is a medication used in this clinical trial to treat patients with metastatic breast cancer that expresses the HER2 protein. It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody that targets the HER2 protein with a chemotherapy drug. This combination allows the medication to specifically target and kill cancer cells that have the HER2 protein on their surface, potentially reducing the growth and spread of the cancer.

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic breast cancer that expresses the HER2 protein. The drug works by targeting and binding to the HER2 protein on cancer cells, delivering a chemotherapy agent directly to the cells to kill them. It is classified as an antibody-drug conjugate, combining a targeted therapy with chemotherapy to enhance its cancer-fighting effects.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It often begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby tissues and lymph nodes. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancer may metastasize to other parts of the body. The progression and symptoms can vary depending on the type and stage of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512721-89-00Protocol codeHER2-Ex PETEstimated enrolment70 patientsSponsorKarolinska University Hospital

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