Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 years or older
• People whose general health and ability to carry out daily activities meets a specific fitness level used in cancer research (ECOG performance status 0–1; confirm with trial site)
• Men and women (pre- or post-menopausal) who have been diagnosed with breast cancer that has spread to the brain, with at least 2 brain tumours that have not yet been treated and are at least 3mm in size, as seen on a brain MRI scan
• People who have had a contrast-enhanced brain MRI scan within two weeks before starting treatment, showing at least 2 brain lesions of 3mm or larger
• People whose brain tumours to be treated are each smaller than 4cm across
• People who have measurable disease according to a standard medical measurement system called RECIST 1.1 (confirm with trial site)
• People who are willing and able to read, understand, and sign a written consent form (or have a legal representative do so on their behalf)
• People who have previously had a type of focused radiation treatment called SRS, as long as the specific brain lesions being targeted in this trial have not previously been treated with SRS
• People who have had a partial surgical removal of a brain tumour, as long as the remaining tumour is smaller than 4cm
• People who are continuing hormonal therapy or anti-HER2 therapy and whose brain tumours have continued to grow or spread during that treatment
• People who have had a gap of at least two weeks since their last general cancer treatment before entering the trial
• People who are able to use contraception for at least 120 days as required by the trial
• People with adequate bone marrow and liver function (confirm with trial site)

Who may not be able to join:

• People with active connective tissue diseases, such as lupus or scleroderma, that are currently needing treatment for a flare-up
• People who have already had all known brain tumours completely surgically removed
• People for whom a tissue sample confirming a breast cancer diagnosis cannot be obtained
• People whose brain tumour being targeted is within 5mm of the optic nerve or the area where the optic nerves meet (optic chiasm), where radiation could affect vision
• People who have received radiotherapy within 2 weeks before starting the trial, or who have not fully recovered from side effects of previous radiation (a shorter 1-week gap may be allowed for limited palliative radiation to areas outside the brain — confirm with trial site)
• People who have received a live or live-weakened vaccine within 30 days before the first dose of the trial treatment
• People who are currently taking part in, or have taken part in, another trial of an experimental treatment, or have used an experimental medical device within the past 4 weeks
• People who have been diagnosed with an immune system deficiency, or who are taking steroid medication above a certain dose (more than 10mg of prednisone or equivalent per day), or any other immune-suppressing medication within the past 7 days
• People who have another active cancer (separate from breast cancer) that is growing or has needed treatment in the past 3 years (certain treated skin cancers and early-stage cancers that have been fully treated may still be eligible — confirm with trial site)
• People who have had a severe allergic reaction to the study drug pembrolizumab or any of its ingredients
• People with an active autoimmune disease that has needed systemic medical treatment in the past 2 years (hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not considered to be in this category)
• People who have a history of lung inflammation (pneumonitis or interstitial lung disease) that needed steroid treatment, or who currently have lung inflammation
• People with an active infection that requires treatment with medication
• People with a known history of HIV
• People with a known history of active Hepatitis B or active Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People with known psychiatric conditions or substance use disorders that would make it difficult to take part in the trial as required
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and for 120 days after the last dose of treatment

Important: Always verify eligibility with the trial site directly before applying.