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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Institut Godinot Reims France
Centre Henri Becquerel Rouen France
Hopital Prive Jean Mermoz Lyon France
Hopital Prive Des Cotes D’armor Plerin France
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Ikdtzqmy Rpylfvsb Du Csvjnp Dh Maqvbvgcodo Montpellier France
Crnrjr Lnki Bkxfzh Lyon France
Ccm dipqeuzlpswnau Epagny Metz Tessy France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
13.12.2021

Trial locations

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.

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 ID:
2024-510703-11-00
Protocol code:
UC-BCG-2011
NCT ID:
NCT05041842
Trial Phase:
Therapeutic exploratory (Phase II)

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