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Study of Tucatinib, Etoposide, and Trastuzumab for Patients with Metastatic HER2+ Breast Cancer After Progression or Capecitabine Toxicity

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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 metastatic HER2-positive breast cancer. This is a form of cancer that has spread beyond the breast and is characterized by the presence of a protein called HER2, which promotes the growth of cancer cells. The study is testing a combination of treatments to see how effective they are in managing this disease. The treatments being used in this trial include tucatinib, oral etoposide (VP16), and trastuzumab. Tucatinib is a medication taken in the form of film-coated tablets, while etoposide is taken as soft capsules. Trastuzumab is administered as a solution for injection or infusion.

The purpose of the study is to evaluate how well this combination of medications works in patients who have experienced disease progression or side effects with previous treatments. Participants in the study will receive these medications over a period of time, and their response to the treatment will be monitored. The study aims to determine the objective response rate, which refers to the percentage of patients whose cancer shrinks or disappears after treatment, within the first six months. The trial will also monitor for any adverse events, which are unwanted effects that may occur during the treatment.

Throughout the study, participants will be closely observed to assess the progression of their cancer and their overall survival. The trial will also explore other factors, such as the duration of response to the treatment and the time it takes for the treatment to start working. This research is important for understanding how these medications can be used together to improve outcomes for patients with metastatic HER2-positive breast cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    Upon joining the clinical trial, the treatment begins with the administration of medications. The primary medications involved are tucatinib, oral etoposide, and trastuzumab.

    The tucatinib is provided in the form of film-coated tablets, available in 150 mg and 50 mg dosages. These tablets are taken orally.

    The oral etoposide is provided in soft capsules, with a dosage of 50 mg. This medication is also taken orally.

    The trastuzumab is administered in two forms: a solution for subcutaneous injection and a powder for concentrate for solution for infusion.

  2. Step 2

    Medication schedule

    The specific schedule for taking these medications will be provided by the healthcare team. It is important to follow the prescribed dosage and frequency as instructed.

    The treatment is designed to be administered over a period of up to six months, during which the response to the medications will be closely monitored.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular assessments will be conducted to evaluate the effectiveness of the treatment. This includes monitoring the objective response rate, which measures how well the cancer responds to the treatment within the first six months.

    Additional assessments may include monitoring for any adverse events or side effects related to the medications.

  4. Step 4

    End of treatment

    At the end of the treatment period, a final evaluation will be conducted to assess the overall response to the treatment.

    The healthcare team will provide guidance on any further steps or follow-up care that may be necessary.

Who can join the trial?

24 criteria

  • The patient must have Metastatic HER2+ Breast Cancer.
  • The disease must have progressed under previous treatment or the patient must have a medical reason not to continue previous treatment.
  • Relevant records of any brain treatment must be available.
  • The heart's pumping ability, known as Left Ventricular Ejection Fraction (LVEF), must be at least 50%.
  • The patient must have adequate organ function, which includes:
    • Absolute Neutrophil Count (ANC) of at least 1.5 x 109/L.
    • Hemoglobin (Hgb) of at least 9 g/dL.
    • Platelet count of at least 100 x 109/L.
    • Bilirubin level of 1.5 times the upper limit of normal, except for patients with Gilbert's disease (up to 2 times the upper limit).
    • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels of 2.5 times the upper limit of normal (up to 5 times for patients with liver metastases).
    • Alkaline Phosphatase (AP) level of 3 times the upper limit of normal (up to 5 times for patients with liver metastases).
    • Serum Creatinine level of 1.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min.
    • If the patient is female and can have children, a negative pregnancy test is required, and effective contraception must be used.
    • If the patient is male, an acceptable method of contraception must be used during the study and for 3 months after.
    • The patient must have health insurance coverage.
    • The patient must be able to give informed consent and comply with study requirements.
    • The patient must be over 18 years old.
    • The patient must have a confirmed diagnosis of HER2+ breast carcinoma with available tumor tissue samples.
    • The patient must have a life expectancy of at least 3 months.
    • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, indicating they are fully active or have some symptoms but do not require bed rest.
    • The patient must be able to swallow capsules.
    • The patient must be willing to participate for the duration of the study and follow study procedures.
    • The patient must have measurable disease as assessed by specific criteria.
    • Patients with brain metastases are eligible if:
      • No urgent treatment is required.
      • At least 21 days have passed since whole-brain radiation therapy, 7 days since stereotactic radiosurgery, or 28 days since surgical removal of brain tumors.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than Metastatic HER2+ Breast cancer cannot participate. This type of cancer is when breast cancer has spread to other parts of the body and has a specific protein called HER2.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to take the study medications, such as tucatinib, oral VP16, or trastuzumab, cannot participate. These are specific drugs used in the treatment being studied.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health requirements set by the study cannot participate. These requirements ensure the safety and effectiveness of the treatment for participants.
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Investigated drugs

  • Tucatinib

    is a medication used in this trial to help treat breast cancer that has spread to other parts of the body. It works by blocking certain proteins that help cancer cells grow, specifically targeting HER2-positive cancer cells. This helps to slow down or stop the growth of the cancer.

  • Oral Etoposide (VP16)

    is a type of chemotherapy drug that is taken by mouth. It works by interfering with the DNA of cancer cells, which prevents them from dividing and growing. This helps to reduce the number of cancer cells in the body.

  • Trastuzumab

    is a medication that targets HER2-positive breast cancer cells. It is a type of targeted therapy that attaches to the HER2 protein on the surface of cancer cells, which can help to stop the cells from growing and dividing. It is often used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

  • Tucatinib

    Tucatinib is taken orally and is currently being studied in clinical trials for its effectiveness in treating metastatic HER2-positive breast cancer. It is often used in combination with other medications like oral etoposide and trastuzumab. Tucatinib works by specifically targeting and blocking the HER2 protein, which is involved in the growth of cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors, which help to slow down or stop the growth of cancer cells.

  • Etoposide

    Etoposide is administered orally and is being evaluated in combination with other drugs for treating metastatic HER2-positive breast cancer. It is a well-established medication in cancer treatment and works by interfering with the DNA of cancer cells, preventing them from dividing and growing. Etoposide is classified as a topoisomerase inhibitor, which helps to stop the spread of cancer by disrupting the DNA replication process.

  • Trastuzumab

    Trastuzumab is given through an intravenous infusion and is widely used in the treatment of HER2-positive breast cancer. It is a monoclonal antibody that specifically targets the HER2 protein on cancer cells, helping the immune system to recognize and destroy these cells. Trastuzumab is part of a group of drugs known as targeted therapies, which aim to attack specific cancer cells while minimizing damage to normal cells.

Investigated diseases

Metastatic 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. In its metastatic form, the cancer has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. The disease progresses as cancer cells continue to grow and invade other tissues, often leading to the formation of new tumors in distant organs. The progression can vary greatly among individuals, with some experiencing rapid spread while others may have a slower progression. Symptoms may include pain, fatigue, and other organ-specific issues depending on where the cancer has spread. The disease is monitored through imaging and other tests to assess the extent of spread and response to any interventions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500743-20-00Protocol codeIC 2021-06Estimated enrolment66 patientsSponsorInstitut Curie

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