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 or older on the day they sign the consent form.
• People diagnosed with metastatic breast cancer that has spread to the brain, where the cancer tests negative for the HER2 protein, confirmed by accepted clinical standards.
• People who have received no more than one round (line) of chemotherapy since their breast cancer spread to other parts of the body.
• People whose brain metastases do not need immediate local treatment (such as radiation or surgery) during the trial, and who either have not previously had brain radiation, or have not previously had brain surgery — or if surgery was done, the treated area has either come back or is not the area planned for radiation.
• People who have at least one brain tumour spot that is 10 mm or larger at its longest point, measurable by MRI scan.
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning mostly able to carry out normal daily activities), assessed within 10 days before starting treatment.
• People who have previously received certain chemotherapy drugs called anthracyclines (such as doxorubicin or epirubicin) and/or taxanes (such as paclitaxel or docetaxel) — either before their cancer came back, during active treatment that did not work, or where the treating doctor has determined these drugs are not suitable as a first treatment at this stage.
• Female patients who are not pregnant, not breastfeeding, and who agree to use contraception as required.
• People who are willing and able to sign the consent form to take part in the study.
• People whose liver, kidneys, blood, and other organs are functioning adequately, confirmed by blood tests taken within 10 days before starting treatment (confirm with trial site for specific values).

Who may not be able to join:

• People whose cancer has spread to the lining around the brain and spinal cord (called leptomeningeal metastasis).
• People whose brain metastasis symptoms are too severe to allow them to cooperate with radiation therapy.
• People who have a condition that prevents proper absorption of food or medication in the gut, who have had most of their stomach removed, or who have had part of the upper small bowel removed, as this may affect how oral medication is absorbed.
• People who have difficulty swallowing or cannot swallow tablets.
• People who have had another serious (invasive) cancer within the past 5 years that is still active or being treated — though people with a history of certain skin cancers, non-invasive breast cancer, or cervical cancer in situ that was treated with the aim of cure are not excluded.
• People who have previously been treated with certain immune checkpoint drugs (anti-PD-1, anti-PD-L1, anti-PD-L2) or similar immune-targeting therapies (such as those targeting CTLA-4, OX40, or CD137).
• People who have a diagnosed immune system deficiency, or who have been taking steroid medications at higher than a low daily dose, or any immune-suppressing medications, within 7 days before the first study treatment.
• People who have had an active autoimmune disease requiring ongoing medication within the past 2 years.
• People who have a history of lung inflammation (non-infectious pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• Female patients with a positive pregnancy test within 72 hours before the first dose of study treatment.
• People who have an active infection currently being treated with medication.
• People with a known history of active tuberculosis (TB).
• People whose heart pumping function (left ventricular ejection fraction) is below 50% or below the normal range set by the testing facility, as shown on a heart ultrasound at screening.
• People with significant heart conditions, including a heart attack, acute coronary event, or heart procedure (such as stent or bypass surgery) within the past 6 months, or moderate-to-severe heart failure (confirm with trial site for classification details).
• People with a known history of HIV infection.
• People with known active hepatitis B or hepatitis C virus infection.

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