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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
MD Anderson Cancer Center	Madrid	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Son Llatzer	Palma	Spain
Salut Sant Joan De Reus	Reus	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Itazjmcq Cpqmkr Dzwxglqyomjtvkkdg	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	31.03.2017

Trial locations

Investigated drugs:

Irinotecan

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.

Investigated diseases:

HER2 negative breast cancer

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 ID:

2024-514999-41-00

Protocol code:

MEDOPP107

NCT ID:

NCT03328884

Trial Phase:

Therapeutic exploratory (Phase II)

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

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