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Clinical Trials for Prevention, Early Detection and Treatment of Breast Cancer Leptomeningeal Metastases

This non-randomized Phase ll trial assesses safety and efficacy of Tucatinib, an experimental drug that blocks the Her2 receptors. The drug is in pill form and is taken in combination with capecitibine (Xeloda) and Herceptin. Earlier studies have shown efficacy for this combination in Her2+ brain metastases. However, this is the first time it is being studied in leptomeningeal disease. Enrollees with cardiac dysfunction are excluded, as are people who have been on capecitibine within the preceding 12 months. Tucatinib was previously known as ONT-380. 

This was a dose escalation study which is now waiting for results. It is looking to see if intrathecal delivery, either through the spine or directly into the brain, is an effective and safe treatment for leptomeningeal disease. See comments and a listing of case studies of this method under leptomeningeal disease.

This Phase l trial is testing the safety and tolerability of AZD1390 in combination with radiation. This new compound blocks cell repair of cancer cells undergoing radiation therapy thus causing them to die. It has been shown to penetrate the brain. Different doses will be given to those enrolled in the trial to find the best dose. 

This Chinese Phase ll study is being done to determine if a form of radiation called tomotherapy is effective for patients with brain metastases or leptomeningeal disease that has not responded to or is progressing after regular whole-brain radiation therapy. Tomotherapy combines computed tomography (CT) with guided intensity modulated radiation therapy (IMRT). The radiation is targeted to the metastases. Patients must have 3 or more brain metastases up to 6 cm in size or leptomeningeal disease.

This Chinese Phase l/ll trial consists of intrathecal chemotherapy (via a spinal puncture) of Pemetrexed (methotrexate) and conformational radiation which is radiation that conforms to the shape of the tumor avoiding other parts of the brain. According to the trial description, this combination of treatments has been shown to be effective in the past but there has not been a clinical trial to test its efficacy.

This Phase l trial is trying to find the safest dose of proton radiation to the brain, spine, and spinal fluid. The study hopes to show that treating all three areas instead of just where metastases are causing symptoms could improve treatment. Proton radiation is safer than regular radiation.  

This is a non-randomized Phase lll study to see if ANG1005 can prolong survival in HER2-negative breast cancer with newly diagnosed leptomemingeal disease and previously treated brain metastases. ANG1005 is a brain-penetrating form of the drug Taxol (paclitaxel).

This is a study of biomarkers (signs) in the spinal fluid of women with breast cancer metastasized to the leptomeningeal. Spinal fluid samples will be taken during the first lumbar puncture performed on the patient in the clinic, in other words, no additional procedure will be required of study participants. This biomarker study is taking place in France.

This is a phase II study prospective study to evaluate high dose methotrexate in breast cancer with leptomeningeal disease in patients with or without brain metastases. It will be looking to see if high dose methotrexate penetrates the blood brain barrier getting into the spinal fluid and affecting bulky leptomeningeal disease. Patients must be triple negative, HER2-positive, and hormone refractory and can not have had whole-brain radiation in the last 6 months or chemotherapy and stereotactic radiosurgery in the last two weeks.

This is a phase II trial taking place in China, that is looking at the safety and efficacy of combining radiotherapy and intrathecal chemotherapy for leptomeningeal disease. Patients will be randomized to receive either: methotrexate or ARA-C (cytarabine) concurrently.

This is a phase II study of patients with any number of prior treatments. Pembrolizumab (Keytruda) is an immumotherapeutic treatment that has been approved for melanoma and certain types of lung cancer, head and neck cancer, lymphoma, and urothelial cancer. It works by stopping cancer cells from shielding themselves from the immune system. Patients must not have had any prior treatment with PD-1 therapy and developed progressive disease.

The purpose of this study is to see if DNA from cancer tumor cells can be found in cerebral spinal fluid before it is possible to find malignant cancer cells/ Those who enter the trial must have symptoms of leptomeningeal metastases such as headache, vision problems, hearing loss, cognitive loss etc. but can not have had previous central nervous system disease including brain metastases.

This is a phase l study to determine the proper dose and safety of afatinib for women with HER2-positive brain metastases. Afatinib has already been approved for certain types of lung cancer and melanoma. It is an immunotherapeutic drug that keeps cancer cells from shielding themselves from the immune system.  There will be groups in the trial each with an escalating dose of afatinib. To enter this trial one previous treatment for brain metastases must have failed, and at least 28 days must have elapsed after whole brain radiation or radiosurgery.

The purpose of this French Phase lll study is to compare the progression free survival of leptomeningeal metastasis with the use of intrathecal delivery of liposomal cytarabine, (a chemotherapy drug) versus treatment of physician’s choice (chemotherapy, hormonal therapy, or targeted therapy) delivered intraveneously (into the veins). Intrathecal delivery of a drug is done by lumber puncture (spinal tap) or through a device placed under the scalp. It infuses the drug directly into the cerebrospinal fluid targeting the cancer cells. Life expectancy must be at least 2 months. Brain metastases are allowed if they are not symptomatic.

This Phase ll study will be looking at whether high-dose methotrexate is effective at controlling leptomeningeal metastasis caused by breast cancer. The methotrexate will be delivered intravenously (into the veins). Patients may also have brain metastases. Everyone in the study receives the treatment.

 In this phase lll trial patients will either receive liposomal cytarabine (chemotherapy) either intravenously (through the veins) or intrathecally (directly into the leptomeninges through a hole in the scalp--See treatment of leptomeningeal disease in this website). Patients can have stable brain metastases but cannot have a mass in the leptomeninges larger than 1 cm. This trial is being done in France.