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Study of tucatinib, pertuzumab and trastuzumab combination for patients with HER2-positive metastatic breast cancer who have brain metastases after local therapy

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 focuses on treating patients with HER2-positive metastatic breast cancer who have developed cancer spread to the brain. The study evaluates a combination treatment using three medications: tucatinib (taken as tablets), pertuzumab, and trastuzumab (both given through infusion into a vein). This treatment approach is being studied in patients whose cancer has progressed in the brain while they were receiving previous treatments.

The purpose of this study is to determine how effective the addition of tucatinib is when combined with pertuzumab and trastuzumab in treating brain metastases. The treatment begins after patients have completed local treatment of their brain tumors through surgery and/or radiation therapy. Patients will receive regular brain scans to monitor how their cancer responds to the treatment.

Throughout the study, patients will take tucatinib tablets daily and receive regular infusions of pertuzumab and trastuzumab. The treatment will continue as long as it remains effective and the side effects are manageable. Patients will have regular check-ups to monitor their health and assess how well the treatment is working. Some patients may also receive additional hormone-blocking treatments such as anastrozole, letrozole, exemestane, or fulvestrant, depending on their specific type of breast cancer.

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

    Initial evaluation

    Your medical team will perform initial tests to confirm your eligibility for the trial, including blood tests to check liver, kidney, and blood cell counts

    You will undergo heart function tests including an ECG (heart rhythm test) and measurement of heart pumping strength

    A brain MRI scan will be performed to assess your condition

  2. Step 2

    Treatment initiation

    You will receive three medications as part of your treatment:

    - Tukysa (tucatinib) tablets taken by mouth

    - Pertuzumab given through an intravenous infusion

    - Trastuzumab given through an intravenous infusion

    Your doctor will provide specific instructions about when to take each medication

  3. Step 3

    Regular monitoring

    You will have regular check-ups to monitor your response to treatment

    Brain scans will be performed to track changes in brain metastases

    Blood tests will be conducted to monitor your body's response to treatment

    Your heart function will be checked periodically

  4. Step 4

    Six-month evaluation

    A key assessment will occur at the 6-month point to evaluate how well the treatment is working

    This evaluation will include brain imaging to check for any changes in your condition

  5. Step 5

    Ongoing treatment

    Treatment will continue as long as it is providing benefit and you are tolerating it well

    Regular assessments will continue throughout the treatment period

    Any side effects will be monitored and recorded using standardized criteria

Who can join the trial?

13 criteria

  • Age 18 or older, both men and women can participate
  • Must have adequate heart function, including: - Normal ECG readings or minor changes that don't need treatment - Normal heart pumping function (ejection fraction) of 50% or higher - No history of serious heart rhythm problems
  • Previous cancer treatment side effects must be resolved or mild
  • Must be on a stable dose of steroids when joining the study
  • For women who can become pregnant: - Negative pregnancy test within 14 days before starting - Must use effective birth control during the study and 7 months after - Hormonal birth control not allowed for patients with hormone-sensitive breast cancer
  • Must have HER2-positive breast cancer confirmed by laboratory tests
  • Must have brain metastases that have gotten worse while on previous treatment with pertuzumab and trastuzumab
  • Must have completed brain treatment (surgery or radiation) within the last 12 weeks
  • Must be able to have brain MRI scans
  • Must have good organ function, including: - Normal kidney function - Adequate liver function - Normal blood cell counts
  • Must have good physical function status (ECOG score of 0-1, meaning able to perform daily activities)
  • Must be willing to follow study requirements, including regular visits and tests
  • Must sign an informed consent form before starting any study procedures

Who cannot join the trial?

13 criteria

  • Prior treatment with tucatinib (an anti-cancer drug targeting HER2-positive breast cancer)
  • Active systemic disease progression outside the brain
  • History of severe allergic reactions to trastuzumab or pertuzumab (targeted therapy drugs)
  • Significant heart problems, including uncontrolled high blood pressure or heart failure
  • Severe liver or kidney dysfunction
  • Active infections requiring systemic treatment
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Any other serious medical condition that could compromise safety
  • Current participation in another clinical trial
  • Previous radiation treatment to the brain within the last 14 days
  • History of other cancers within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Psychological, social, or geographical conditions that would prevent proper follow-up
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Investigated drugs

Tucatinib is a medication that targets specific proteins (HER2) in breast cancer cells. It's a tablet that helps block the growth and spread of cancer cells, particularly in cases where the cancer has spread to the brain. Pertuzumab is an antibody treatment that attaches to HER2-positive breast cancer cells. It works by blocking signals that cause cancer cells to grow and divide, and it helps the immune system identify and fight cancer cells. Trastuzumab is also an antibody treatment specifically designed for HER2-positive breast cancer. It works by attaching to the HER2 proteins on cancer cells, helping to slow down or stop their growth. It also helps the body's immune system fight the cancer cells. These three medications are used together to treat breast cancer that has spread to the brain, particularly in patients whose cancer cells have high levels of a protein called HER2.

What is already known about the treatment

  • Tucatinib

    An oral tyrosine kinase inhibitor specifically targeting HER2-positive breast cancer that can cross the blood-brain barrier, making it particularly effective for treating brain metastases. This medication works by blocking the HER2 protein signals that promote cancer cell growth, and it is typically administered in tablet form as part of combination therapy with other targeted treatments. The drug has shown significant promise in clinical trials for patients with HER2-positive metastatic breast cancer who have developed brain metastases.

  • Pertuzumab

    A targeted monoclonal antibody therapy administered intravenously that works by preventing HER2-positive cancer cells from pairing with other HER2 receptors, effectively blocking cell growth signals. This medication is commonly used in combination with other HER2-targeted therapies to provide a more comprehensive treatment approach for HER2-positive metastatic breast cancer. It belongs to the class of HER2 dimerization inhibitors and has demonstrated improved outcomes when used as part of combination therapy.

  • Trastuzumab

    A pioneering HER2-targeted monoclonal antibody given through intravenous infusion that attaches to HER2 proteins on cancer cells, blocking growth signals and marking these cells for destruction by the immune system. This medication has been a cornerstone in the treatment of HER2-positive breast cancer for over two decades and is often used in combination with other targeted therapies. It belongs to the class of HER2 receptor antagonists and has shown significant efficacy in both early-stage and metastatic breast cancer.

Investigated diseases

HER2-Positive Metastatic Breast Cancer with Brain Metastases - A form of breast cancer that tests positive for a protein called HER2 (Human Epidermal Growth Factor Receptor 2) and has spread beyond the breast to distant parts of the body, specifically affecting the brain. In this condition, cancer cells have an excess of HER2 protein on their surface, which promotes cancer cell growth. The disease begins in the breast tissue and later spreads (metastasizes) to form secondary tumors in the brain. This particular presentation involves a situation where the cancer progression is observed primarily in the brain while other metastatic sites remain stable. The presence of brain metastases represents an advanced stage of the disease that requires specific medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510703-11-00Protocol codeUC-BCG-2011Estimated enrolment55 patientsSponsorUnicancer

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