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Study on Trastuzumab, Pertuzumab, and Tucatinib for Patients with Stage II-III HER2-Positive Breast Cancer Without Chemotherapy

Registered 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 a type of breast cancer known as HER2-positive breast cancer. This specific type of cancer has higher levels of a protein called HER2, which promotes the growth of cancer cells. The study is exploring a treatment approach that does not involve traditional chemotherapy. Instead, it uses a combination of three medications: trastuzumab, pertuzumab, and tucatinib. These medications are designed to target and block the HER2 protein, potentially slowing down or stopping the growth of cancer cells.

The purpose of the study is to evaluate the safety and feasibility of this chemotherapy-free treatment regimen in patients with stage II-III HER2-positive breast cancer. Participants in the study will receive the medications before surgery, a phase known as neoadjuvant treatment. The study will monitor the participants for any side effects and assess how well the cancer responds to the treatment. The medications are administered in different forms: trastuzumab and pertuzumab are given as solutions for infusion, which means they are delivered directly into the bloodstream through a vein, while tucatinib is taken orally as a tablet.

The study will follow participants through their treatment journey, observing any changes in the cancer and recording any adverse effects. The goal is to determine if this combination of medications can effectively treat HER2-positive breast cancer without the need for chemotherapy, which often comes with significant side effects. The study will also look at the long-term outcomes, such as the absence of cancer at the time of surgery and overall survival rates, to provide a comprehensive understanding of 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

    Joining the study

    Upon joining the study, the patient will have already provided signed written informed consent.

    The patient must meet specific laboratory requirements, including adequate bone marrow, liver, and kidney function.

    The patient must have a confirmed diagnosis of stage II-III HER2-positive breast cancer.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of three medications: trastuzumab, pertuzumab, and tucatinib.

    Trastuzumab is administered as an intravenous infusion.

    Pertuzumab is also given as an intravenous infusion.

    Tucatinib is taken orally.

  3. Step 3

    Treatment duration

    The treatment is administered over a period leading up to surgery.

    The exact duration of the treatment phase is determined by the study protocol and the patient's response to the medications.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, the patient will be monitored for any adverse events or side effects.

    Regular imaging tests, such as MRI, will be conducted to assess the response of the tumor to the treatment.

    The patient's overall health and response to the treatment will be evaluated continuously.

  5. Step 5

    Surgery

    Following the treatment phase, surgery will be performed to remove any remaining cancerous tissue.

    The success of the treatment will be assessed based on the absence of cancer cells in the tissue removed during surgery.

  6. Step 6

    Post-treatment follow-up

    After the completion of the treatment and surgery, the patient will be monitored for any signs of cancer recurrence.

    Follow-up visits will be scheduled to ensure the patient's continued health and to address any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • You must sign a written informed consent form, which means you agree to participate after understanding the study details.
  • Your lab tests must meet certain requirements within 21 days before joining the study:
    • Adequate bone marrow function: This means your blood tests show enough white blood cells and platelets.
    • Adequate liver function: Your liver tests should be within a safe range. If you have Gilbert's syndrome, your bilirubin can be slightly higher if there's no bile duct blockage.
    • Adequate kidney function: Your kidneys should be working well, as shown by a creatinine clearance test.
    • You must have a confirmed diagnosis of primary invasive breast cancer, which means the cancer has spread into surrounding breast tissue.
    • Your breast cancer should be at stage II or IIIA, which is determined by the size of the tumor and if it has spread to nearby lymph nodes.
    • Your cancer must show HER2 overexpression, meaning a specific protein is present in high amounts on the cancer cells.
    • The cancer's estrogen and progesterone receptor status should be known. If the cancer is ER-negative or PR-negative, less than 10% of the cancer cells react to these hormones.
    • Your WHO performance status should be 0-1, indicating you are fully active or have some symptoms but can still do light work.
    • You must be at least 18 years old.
    • Your left ventricular ejection fraction (LVEF) should be 50% or higher, showing your heart is pumping well.
    • You should be eligible for neoadjuvant treatment, which is therapy given before the main treatment to shrink the tumor.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than HER2-positive breast cancer cannot participate. HER2-positive means that the cancer has a protein that promotes the growth of cancer cells.
  • Patients who are not in stage II or III of breast cancer are excluded. These stages refer to the size of the tumor and whether it has spread to nearby lymph nodes.
  • Patients who are not able to safely receive the study medications, which include trastuzumab, pertuzumab, and tucatinib, cannot participate. These are medications used to treat HER2-positive breast cancer.
  • Patients who are not female or male are excluded, as the study is open to both genders.
  • Patients who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

  • Trastuzumab

    is a medication used to treat HER2-positive breast cancer. It works by targeting the HER2 protein on the surface of cancer cells, helping to stop their growth and spread.

  • Pertuzumab

    is another medication used in the treatment of HER2-positive breast cancer. It works in combination with trastuzumab to block the HER2 protein more effectively, providing a stronger defense against cancer cell growth.

  • Tucatinib

    is a medication that targets the HER2 protein inside cancer cells. It helps to prevent the cancer cells from growing and spreading, and is used alongside trastuzumab and pertuzumab to enhance the treatment's effectiveness.

What is already known about the treatment

  • Trastuzumab

    This medication is administered intravenously and is currently well-established in medical literature for treating HER2-positive breast cancer. It is primarily used to target and inhibit the growth of cancer cells that overexpress the HER2 protein. Trastuzumab works by binding to the HER2 receptors on the surface of cancer cells, blocking them from receiving growth signals. It is classified as a monoclonal antibody.

  • Pertuzumab

    Administered intravenously, pertuzumab is recognized in medical literature as a treatment for HER2-positive breast cancer. It is used to prevent cancer cell growth by targeting the HER2 receptor. Pertuzumab binds to a different part of the HER2 receptor than trastuzumab, providing a complementary mechanism of action. It is also classified as a monoclonal antibody.

  • Tucatinib

    This medication is taken orally and is gaining recognition in medical literature for its role in treating HER2-positive breast cancer. Tucatinib is used to inhibit the growth of cancer cells by blocking the HER2 and HER3 signaling pathways inside the cells. It is classified as a tyrosine kinase inhibitor, which interferes with specific enzymes involved in cancer cell growth.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically 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, which may be detected through physical examination or imaging tests. Over time, if untreated, the cancer may metastasize to other parts of the body. The progression and symptoms can vary widely among individuals, depending on the type and stage of the cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518192-61-00Protocol codeN21TRVEstimated enrolment30 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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