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Study on the Effectiveness and Safety of Trastuzumab, Tucatinib, and Vinorelbine for Patients with Advanced HER2-Positive 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 non-resectable locally advanced or metastatic breast cancer. The study is investigating the effectiveness and safety of a combination of treatments, which includes the medications Trastuzumab, Tucatinib, and Vinorelbine. These medications are being tested together to see how well they work in treating this specific type of breast cancer.

The purpose of the study is to evaluate how effective this combination of medications is in treating the cancer. Participants in the study will receive the combination of these medications, and some may receive a placebo. The study will monitor the participants over a period of time to observe the response of the cancer to the treatment. This includes looking at how the cancer shrinks or grows, and how long the effects of the treatment last. The study will also assess the safety of the treatment by monitoring any side effects that participants may experience.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI to check for any changes in the cancer, especially in the brain if there are concerns about metastasis, which is when cancer spreads to other parts of the body. The study aims to provide valuable information on the potential benefits and risks of using this combination of medications for treating HER2-positive breast cancer.

The research process

The trial runs in 7 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, informed consent is required. This involves understanding the study's purpose and procedures.

    Eligibility is confirmed through various criteria, including age, health status, and previous treatments.

  2. Step 2

    Baseline assessments

    Initial assessments are conducted to establish a baseline. These include imaging tests like MRI to check for brain metastases and other health evaluations.

    Blood tests and other diagnostic procedures are performed to ensure adequate organ function and overall health.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of three medications: tucatinib, trastuzumab, and vinorelbine.

    Tucatinib is taken orally in the form of film-coated tablets, available in 50 mg and 150 mg doses.

    The specific dosage and frequency of each medication are determined by the study protocol and the patient's health status.

  4. Step 4

    Ongoing treatment and monitoring

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects.

    This includes periodic imaging tests, blood tests, and health evaluations.

    Adjustments to medication dosages may be made based on the patient's response and any side effects experienced.

  5. Step 5

    Evaluation of treatment response

    The primary goal is to evaluate the objective response rate, which includes complete and partial responses to the treatment.

    Secondary evaluations focus on progression-free survival, duration of response, and overall survival.

  6. Step 6

    Quality of life assessments

    Quality of life is assessed using questionnaires to evaluate changes in health status and daily functioning.

    These assessments help determine the impact of treatment on overall well-being.

  7. Step 7

    Completion of study participation

    Participation in the study continues until the treatment is completed or until the study's end date, estimated to be in August 2026.

    Final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

18 criteria

  • Provide a written and signed agreement to participate in the study before any study-related procedures begin.
  • Have a heart function test result showing a **left ventricular ejection fraction (LVEF)** of 50% or higher. This measures how well your heart pumps blood.
  • If you are a woman who can have children, you must have a negative pregnancy test.
  • Be at least 18 years old, whether male or female.
  • Have a confirmed **HER2-positive** status, which is a specific type of breast cancer, as determined by a local lab.
  • Have received at least two previous treatments targeting **HER2**, including taxanes and trastuzumab. Other treatments like pertuzumab, T-DM1, trastuzumab-deruxtecan, and anti-HER2 TKI agents are also acceptable.
  • Have a measurable disease based on specific criteria, meaning there is at least one tumor outside the bones that can be measured accurately.
  • Undergo a brain scan called **MRI** at the start of the study. You must meet one of the following conditions regarding brain metastases (cancer spread to the brain):
    • No signs of brain metastases.
    • Untreated brain metastases that do not need immediate treatment.
    • Previously treated brain metastases that are stable or have progressed but do not need immediate treatment.
    • If treated for new brain lesions, certain timeframes must be met before starting the study treatment, and other disease sites must be present.
    • Have an **ECOG Performance Status** of 0 or 1, which indicates how well you can perform daily activities.
    • Have a life expectancy of at least 12 weeks.
    • Have adequate organ and bone marrow function, which includes:
      • A certain level of **neutrophils** (a type of white blood cell) and **platelets** (cells that help with blood clotting).
      • A **hemoglobin** level of at least 9g/dL, which is a measure of red blood cells.
      • Normal or near-normal **kidney function** as shown by creatinine levels.
      • Normal or near-normal **liver function** as shown by bilirubin, AST, and ALT levels.
      • Normal or near-normal **alkaline phosphatase** levels, which can indicate bone or liver health.

Who cannot join the trial?

9 criteria

  • Patients who have a type of breast cancer that is not **HER2-positive**. **HER2-positive** means the cancer cells have more of a protein called HER2, which can make the cancer grow faster.
  • Patients who have breast cancer that can be removed by surgery. **Non-resectable** means the cancer cannot be taken out with surgery.
  • Patients who have breast cancer that is not **locally advanced** or **metastatic**. **Locally advanced** means the cancer has spread to nearby areas, and **metastatic** means it has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who have other medical conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study drugs or their ingredients.
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Investigated drugs

  • Trastuzumab

    is a medication used to treat certain types of breast cancer. It works by targeting and blocking the function of a protein called HER2, which can promote the growth of cancer cells. In this trial, it is used in combination with other medications to treat HER2-positive breast cancer that cannot be surgically removed or has spread to other parts of the body.

  • Tucatinib

    is a medication that helps to stop the growth of cancer cells by specifically targeting the HER2 protein. It is used in combination with other treatments to enhance their effectiveness in managing HER2-positive breast cancer.

  • Vinorelbine

    is a type of chemotherapy that works by interfering with the growth and spread of cancer cells. It is used in this trial to help control the progression of HER2-positive breast cancer when combined with other targeted therapies.

What is already known about the treatment

  • Trastuzumab

    This medication is administered intravenously and is used in the treatment of HER2-positive breast cancer. It is well-established in medical literature and is commonly used in clinical practice. Trastuzumab works by binding to the HER2 receptor on cancer cells, inhibiting their growth and survival. It is classified as a monoclonal antibody.

  • Tucatinib

    Tucatinib is taken orally and is currently being studied for its effectiveness in treating HER2-positive breast cancer. It is a newer medication in the medical field, with ongoing research to establish its role. Tucatinib specifically inhibits the HER2 protein, blocking signals that promote cancer cell growth. It belongs to the class of tyrosine kinase inhibitors.

  • Vinorelbine

    This medication is administered intravenously and is used in combination with other drugs to treat HER2-positive breast cancer. It is a well-known chemotherapy agent in medical literature. Vinorelbine works by interfering with the division of cancer cells, leading to their death. It is classified as a vinca alkaloid.

Investigated diseases

HER2-positive breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which promotes the growth of cancer cells. It is considered aggressive due to its rapid growth and spread compared to other types of breast cancer. In cases where the cancer is non-resectable, it means that it cannot be surgically removed, often due to its location or size. When it is locally advanced, the cancer has spread beyond the breast to nearby tissues or lymph nodes but not to distant organs. Metastatic HER2-positive breast cancer indicates that the cancer has spread to other parts of the body, such as the bones, liver, or brain. The progression of this disease can vary, but it typically involves the cancer cells continuing to grow and spread if not effectively managed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512590-27-00Protocol codeGEICAM/2020-08Estimated enrolment49 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer De Mama

sourced from the EU Clinical Trials Register and site verification

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