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Study on Irinotecan for Brain Metastases in Patients with HER2-Negative Breast Cancer

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 is focused on studying a type of breast cancer known as HER2-negative metastatic breast cancer, which has spread to the brain. The study is investigating the effects of a treatment called nal-IRI, which is a form of the drug irinotecan. This medication is given as an infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective and safe nal-IRI is for patients whose cancer has progressed in the brain despite previous treatments like whole-brain radiation therapy or surgery.

Participants in the study will receive the nal-IRI treatment and will be monitored to see how their brain metastases respond. The study will look at whether the cancer in the brain shrinks or disappears, and how long any positive effects last. The trial will also assess the overall health and safety of the participants while they are receiving the treatment. The study is designed to gather information over a period of time to understand the potential benefits and risks of using nal-IRI for this specific type of breast cancer.

Throughout the study, medical professionals will use specific criteria to measure the response of the brain metastases to the treatment. These criteria help ensure that the results are consistent and reliable. The trial aims to provide valuable insights into whether nal-IRI can be a beneficial treatment option for patients with HER2-negative metastatic breast cancer that has spread to the brain.

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 visit

    Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A blood test is performed to ensure sufficient organ and marrow function. This includes checking blood cell counts and liver and kidney function.

    A pregnancy test is conducted for participants of childbearing potential.

    Participants are required to sign a consent form, indicating understanding and agreement to participate in the study.

  2. Step 2

    Treatment administration

    The treatment involves the administration of Onivyde pegylated liposomal, which contains the active substance irinotecan.

    The medication is given as an infusion directly into a vein (intravenous route).

    The dosage and frequency of administration are determined by the study protocol and will be explained by the healthcare team.

  3. Step 3

    Regular monitoring

    Regular visits are scheduled to monitor health and response to treatment.

    These visits include physical examinations, blood tests, and imaging studies to assess the size of brain metastases.

    Participants are monitored for any side effects or adverse reactions to the treatment.

  4. Step 4

    Response assessment

    The effectiveness of the treatment is evaluated using specific criteria to measure changes in brain metastases.

    The criteria include the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) and other volumetric parameters.

    The healthcare team will explain the results and any necessary adjustments to the treatment plan.

  5. Step 5

    End of treatment

    At the end of the treatment period, a final assessment is conducted to evaluate overall health and treatment outcomes.

    Participants may be required to undergo additional tests and provide feedback on their experience during the study.

    The healthcare team will discuss any further steps or follow-up care needed after the study concludes.

Who can join the trial?

14 criteria

  • Must be a female or male over 18 years old.
  • Must have a life expectancy of more than 12 weeks.
  • If able to have children, must agree to use a reliable method of birth control during the study and have a negative pregnancy test before starting the study and at the end of treatment.
  • Must be able to understand and willing to sign a written informed consent form, which explains the study and its risks.
  • Must have enough organ and bone marrow function as follows:
    • Blood health: Enough white blood cells (absolute neutrophil count ≥ 1.5 x 109/L), platelets (≥ 100 x 109/L), and hemoglobin (≥ 9 mg/dL).
    • Liver health: Total bilirubin ≤ 1.5 mg/dL and liver enzymes (AST/ALT) ≤ 2.5 times the normal limit.
    • Kidney health: Creatinine ≤ 1.5 times the normal limit, or creatinine clearance ≥ 60 mL/min/1.73 m2 if creatinine levels are higher than normal.
    • Must have a diagnosis of metastatic breast cancer, which means the cancer has spread to other parts of the body.
    • Must have been treated with taxanes (a type of chemotherapy) before joining the study, unless there is a medical reason not to.
    • Must have had at least one previous chemotherapy treatment for advanced cancer.
    • Must show evidence of new or stable/progressing brain metastases (cancer spread to the brain) after previous treatments like whole-brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), or surgery.
    • Must have at least one measurable brain lesion (cancer spot in the brain) that is 10 mm or larger on a specific type of MRI scan. If brain metastases are stable, at least one measurable lesion outside the brain is needed.
    • Must have HER2-negative breast cancer, which means the cancer does not have high levels of the HER2 protein. This is determined by specific tests (immunohistochemistry or FISH).
    • Must have an ECOG performance status of less than 2, which means the patient is able to carry out all self-care but unable to carry out any work activities. They are up and about more than 50% of waking hours.

Who cannot join the trial?

5 criteria

  • Patients with a type of breast cancer that is not HER2-negative. HER2 is a protein that can affect the growth of cancer cells.
  • Patients whose breast cancer has not spread to the brain or nervous system.
  • Patients who do not have measurable cancer spread (metastases) in the brain.
  • Patients who have not shown cancer progression in the brain after treatments like WBRT (whole-brain radiation therapy), SRS (stereotactic radiosurgery), or surgery.
  • Patients who do not meet the specific criteria for cancer progression as determined by the RANO-BM criteria, which is a way to measure brain metastases.
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Investigated drugs

nal-IRI is a medication being studied for its potential to help treat brain metastases in patients with a specific type of breast cancer known as HER2-negative breast cancer. This medication is being tested to see if it can effectively reduce the size of brain tumors in patients whose cancer has spread to the brain and has continued to grow despite previous treatments like whole-brain radiation therapy, surgery, or other targeted therapies. The goal of using nal-IRI in this trial is to see if it can improve the condition of the brain tumors and help manage the disease more effectively.

What is already known about the treatment

nal-IRI – Nal-IRI is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its effectiveness in treating brain metastases in patients with HER2-negative metastatic breast cancer. The main therapeutic use of nal-IRI in this context is to target cancer that has spread to the brain and is not responding to other treatments like whole-brain radiation therapy or surgery. At the molecular level, nal-IRI works by delivering a chemotherapy drug called irinotecan in a special formulation that helps it reach and attack cancer cells more effectively. It is classified as an antineoplastic agent, which means it is used to stop the growth of cancer cells.

Investigated diseases

HER2-negative metastatic breast cancer with nervous system involvement – This type of breast cancer does not have an excess of the HER2 protein on its surface, which is a common target for certain cancer treatments. It has spread beyond the breast and nearby lymph nodes to other parts of the body, including the brain or spinal cord. The disease progresses as cancer cells grow and form new tumors in the central nervous system. These metastases can cause neurological symptoms depending on their location and size. Over time, the cancer may continue to spread to other areas of the body. The progression can lead to increased neurological complications as the disease advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514999-41-00Protocol codeMEDOPP107Estimated enrolment56 patientsSponsorMedica Scientia Innovation Research S.L.

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