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Study on Tucatinib, Capecitabine, and Trastuzumab for Patients with HER2-Positive Breast Cancer and Leptomeningeal Metastases

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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 specific type of breast cancer known as HER2-positive metastatic breast cancer, which has spread to the protective membranes covering the brain and spinal cord, called the meninges. This condition is referred to as leptomeningeal metastases. The study aims to evaluate the effectiveness of a combination of three treatments: Tucatinib, Capecitabine, and Trastuzumab. Tucatinib and Capecitabine are taken as tablets, while Trastuzumab is administered directly into the fluid surrounding the brain and spinal cord, known as the cerebrospinal fluid (CSF).

The purpose of the study is to assess how well this combination of treatments works in improving the survival rate of patients over a period of 12 months. Participants in the study will receive these medications and will be monitored for their response to the treatment. The study will also look at how the treatment affects symptoms related to the cancer's spread to the meninges, as well as the overall quality of life of the participants. Additionally, the study will collect blood and CSF samples to analyze the concentration of the treatments and to study any genetic changes in the cancer cells.

Throughout the study, participants will undergo regular assessments, including imaging tests like MRI to monitor the cancer's progression, and evaluations of their cognitive function. The study will also track any side effects experienced by the participants to ensure the safety of the treatment combination. The trial is expected to continue until 2027, with the aim of providing valuable insights into the treatment of this challenging form 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.

Step 1
Initial treatment phase
Begin taking capecitabine and tucatinib orally. Capecitabine is available in 500 mg and 150 mg film-coated tablets, while tucatinib is available in 50 mg and 150 mg film-coated tablets.
The dosage and frequency of these medications will be determined by the healthcare provider based on individual needs and conditions.
Step 2
Intrathecal therapy
Receive trastuzumab administered as a solution for infusion directly into the cerebrospinal fluid (CSF). This is known as intrathecal therapy.
The administration schedule will be provided by the healthcare team, ensuring the treatment is tailored to the specific medical condition.
Step 3
Monitoring and assessments
Undergo regular monitoring to assess the effectiveness of the treatment. This includes evaluating overall survival rate at 12 months and progression-free survival.
Regular assessments will also include checking for any side effects or cognitive changes using standardized scales and questionnaires.
Step 4
Ancillary studies
Participate in additional studies involving blood and CSF samples to measure treatment concentrations and analyze genomic alterations.
These studies aim to provide further insights into the treatment's impact and the biological changes occurring during the trial.
Step 5
Follow-up
Continue with follow-up visits as scheduled by the healthcare provider to monitor long-term outcomes and any late-onset effects of the treatment.
The follow-up phase is crucial for ensuring ongoing health and well-being after the completion of the main treatment phases.

Who can join the trial?

19 criteria

The patient must have signed a written informed consent form before any trial-specific procedures. If the patient cannot physically sign, a trusted person can confirm the patient's consent in writing.
If the patient has symptoms from brain or leptomeningeal metastasis, local treatments like surgery or radiation are allowed up to 2 weeks before joining the trial, but should have been completed no more than 8 weeks before joining, with no need for immediate re-treatment.
The patient must have adequate blood health, which means having enough white blood cells, platelets, and hemoglobin within 14 days before joining the trial.
The patient must have adequate liver health, with specific levels of bilirubin and liver enzymes within 14 days before joining the trial.
The patient must have normal kidney function, with a creatinine clearance of at least 60 mL/min within 14 days before joining the trial.
The patient must have adequate heart health, shown by a normal heart tracing (ECG) and specific heart function measurements.
Any side effects from previous cancer treatments or surgeries must be resolved to a mild level, except for hair loss or other non-risky side effects.
Women who can have children must have a negative pregnancy test within 14 days before joining the trial.
Women who can have children and male patients must agree to use effective birth control during the trial and for 7 months after treatment. Hormonal birth control is not allowed for patients with hormone-sensitive cancer.
The patient must be part of the social security system or an equivalent system.
The patient must be willing and able to follow the trial's rules, including attending visits, following the treatment plan, and undergoing tests and exams.
The patient must be at least 18 years old.
The patient must have confirmed metastatic breast cancer, which means the cancer has spread to other parts of the body.
The patient must have confirmed **HER2-positive** breast cancer, which is a specific type of cancer identified by certain tests.
The patient must have proven leptomeningeal progression, shown by specific findings on an MRI or the presence of cancer cells in the cerebrospinal fluid.
The patient must have a disease that can be measured according to specific criteria.
The patient must have an **ECOG Performance Status** of 0-2, which is a scale that measures how well the patient can perform daily activities.
The patient must have a life expectancy of at least 2 months.
The patient must be on a stable dose of steroids for at least 5 days before joining the trial.

Who cannot join the trial?

6 criteria

Patients who do not have **HER2-amplified metastatic breast cancer**. This means the cancer cells do not have higher than normal levels of a protein called HER2.
Patients without **leptomeningeal metastases (LM)**. This refers to cancer that has spread to the thin layers of tissue covering the brain and spinal cord.
Patients who do not require **intrathecal therapy**. This is a treatment where medicine is delivered directly into the space around the spinal cord.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centr Georges Francois Leclerc
Dijon, France
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Centre Francois Baclesse
Caen, France
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Centre Henri Becquerel
Rouen, France

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Investigated drugs

Tucatinib
is a medication used in this trial to help treat breast cancer that has spread to the brain. It works by blocking certain proteins that help cancer cells grow, specifically targeting HER2-positive cancer cells.
Capecitabine
is a type of chemotherapy that is used to treat breast cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.
Trastuzumab
is a medication administered directly into the cerebrospinal fluid in this trial. It is used to target and block the HER2 protein on cancer cells, which can help slow or stop the growth of the cancer.

What is already known about the treatment

Tucatinib
Tucatinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating HER2-positive metastatic breast cancer with leptomeningeal metastases. It is classified as a tyrosine kinase inhibitor and works by blocking the HER2 protein, which is involved in the growth and spread of cancer cells. This medication is being evaluated for its potential to improve survival rates in patients with this specific type of cancer.
Capecitabine
Capecitabine is an oral medication that is part of ongoing clinical trials for HER2-positive metastatic breast cancer with leptomeningeal metastases. It is a chemotherapy drug that belongs to the class of antimetabolites, which interfere with DNA production in cancer cells, thereby inhibiting their growth. This drug is being tested for its ability to enhance treatment outcomes when used in combination with other therapies.
Trastuzumab
Trastuzumab is administered directly into the cerebrospinal fluid and is under investigation in clinical trials for its role in treating HER2-positive metastatic breast cancer with leptomeningeal metastases. It is a monoclonal antibody that targets the HER2 protein on cancer cells, helping to slow or stop their growth. This medication is being studied for its potential to improve survival rates when used alongside other treatments.

Investigated diseases

Metastatic Breast Cancer
This is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It is characterized by the presence of cancer cells in distant organs, which can lead to various symptoms depending on the affected area. The disease progresses as cancer cells continue to grow and invade other tissues, often leading to complications in the organs involved. Metastatic breast cancer is considered a chronic condition that requires ongoing management to control its spread and alleviate symptoms.
Leptomeningeal Metastases
This condition occurs when cancer cells spread to the membranes surrounding the brain and spinal cord, known as the leptomeninges. It is often associated with advanced stages of cancer, particularly breast cancer, lung cancer, and melanoma. The progression of leptomeningeal metastases can lead to neurological symptoms such as headaches, seizures, and changes in mental status. As the disease advances, it can cause significant impairment in neurological function due to the involvement of the central nervous system.