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Study of Trastuzumab Deruxtecan with or without Pertuzumab for Patients with HER2-positive Metastatic Breast Cancer

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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 a type of breast cancer known as HER2-positive metastatic breast cancer. This is a form of cancer that has spread beyond the breast and is characterized by an overexpression of a protein called HER2. The study is investigating the effectiveness of a new treatment called Trastuzumab Deruxtecan (T-DXd), which may be used alone or in combination with another drug called Pertuzumab. These treatments are being compared to a combination of drugs that includes a Taxane (such as Docetaxel or Paclitaxel), Trastuzumab, and Pertuzumab.

The purpose of the study is to evaluate how well these treatments work in controlling the cancer. Participants in the study will receive one of these treatment combinations, which are given as infusions directly into the bloodstream. The study will monitor the participants over time to see how the cancer responds to the treatment and to check for any side effects. The study will also look at the overall health and quality of life of the participants during the treatment period.

This trial aims to provide more information about the best treatment options for people with HER2-positive metastatic breast cancer. By comparing these different treatment approaches, researchers hope to find the most effective way to manage this type of cancer and improve outcomes for patients. The study is expected to continue for several years to gather comprehensive data on the treatments' effectiveness and safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of breast cancer, and previous treatments.

    The study focuses on individuals with HER2-positive metastatic breast cancer.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

  3. Step 3

    Treatment administration

    The treatment involves the administration of medications through intravenous use.

    Medications include trastuzumab deruxtecan (also known as T-DXd), pertuzumab, docetaxel, paclitaxel, and trastuzumab.

    The specific combination and dosage depend on the group to which the participant is assigned.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    Assessments include imaging tests to track disease progression and blood tests to measure drug levels and immune response.

  5. Step 5

    Follow-up

    Participants continue to be monitored for a period after the treatment phase to evaluate long-term effects and overall survival.

    The study aims to measure outcomes such as progression-free survival and overall survival.

Who can join the trial?

8 criteria

  • Patients must be at least 18 years old.
  • Must have breast cancer that is advanced or metastatic. This means the cancer has spread beyond the breast to other parts of the body.
  • The cancer must be confirmed as HER2-positive. This is a specific type of breast cancer that has more of a protein called HER2, which can promote the growth of cancer cells.
  • The cancer can be either hormone receptor-positive or hormone receptor-negative. This refers to whether the cancer cells have receptors for hormones like estrogen or progesterone, which can affect how the cancer grows.
  • Patients should not have had any previous chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. However, they can have had one previous line of endocrine therapy (hormone therapy) in the metastatic setting.
  • If patients have had chemotherapy or HER2-targeted therapy before, it should have been more than 6 months before the cancer became metastatic.
  • Patients must have adequate organ and bone marrow function as defined by the study protocol. This means their organs and bone marrow are working well enough to participate in the study.
  • Patients must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to carry out light work.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer that is not HER2-positive metastatic breast cancer cannot participate. HER2-positive means the cancer has a protein that promotes the growth of cancer cells, and metastatic means the cancer has spread to other parts of the body.
  • Patients who have already received treatment for their HER2-positive metastatic breast cancer may not be eligible.
  • Patients with serious health conditions that could interfere with the study treatment or affect their safety may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
  • Patients who have participated in another clinical trial recently may be excluded.
  • Patients with known allergies to the study drugs or their ingredients cannot participate.
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Investigated drugs

  • Trastuzumab Deruxtecan (T-DXd)

    is a medication used in this clinical trial to treat HER2-positive metastatic breast cancer. It is designed to target and attach to the HER2 protein on cancer cells, delivering chemotherapy directly to the cancer cells to help stop their growth and spread.

  • Pertuzumab

    is another medication used in the trial, often in combination with other treatments. It works by attaching to the HER2 protein on cancer cells, similar to Trastuzumab Deruxtecan, and helps to block the signals that encourage cancer cell growth.

  • Taxane

    is a type of chemotherapy drug included in the trial. It works by interfering with the normal function of microtubules during cell division, which helps to stop the growth of cancer cells.

  • Trastuzumab

    is a medication that targets the HER2 protein on cancer cells. It is used in combination with other drugs in this trial to help slow or stop the growth of cancer cells that have too much HER2 protein.

What is already known about the treatment

  • Trastuzumab Deruxtecan

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating HER2-positive metastatic breast cancer. It is a targeted therapy that combines an antibody with a chemotherapy drug, specifically designed to deliver the chemotherapy directly to cancer cells. Trastuzumab Deruxtecan works by binding to the HER2 protein on cancer cells, allowing the attached chemotherapy to enter and kill the cells. It is classified as an antibody-drug conjugate.

  • Pertuzumab

    This medication is also administered intravenously and is used in combination with other drugs to treat HER2-positive metastatic breast cancer. It is a monoclonal antibody that targets the HER2 receptor on cancer cells, preventing them from receiving growth signals. By blocking these signals, Pertuzumab helps to slow or stop the growth of cancer cells. It is classified as a monoclonal antibody therapy.

Investigated diseases

HER2-positive metastatic breast cancer – This is a type of breast cancer characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is considered metastatic when the cancer has spread beyond the breast to other parts of the body. The disease often progresses through stages, starting from localized tumors in the breast and potentially advancing to distant organs such as the liver, lungs, or brain. The presence of HER2-positive cancer cells can lead to more aggressive tumor growth compared to other types of breast cancer. As the disease progresses, patients may experience symptoms related to the spread of cancer, such as pain or organ dysfunction, depending on the areas affected. The progression of the disease is typically monitored through imaging studies and clinical assessments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505249-24-00Protocol codeD967UC00001Estimated enrolment1 134 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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