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 who are 18 years of age or older, of any gender
• People who have been diagnosed with breast cancer that has tested negative for the HER2 protein, based on the most recent tumour sample
• People with hormone receptor-positive (ER positive) breast cancer who have already received a specific type of targeted therapy called a CDK4/6 inhibitor along with hormone therapy, either for advanced/spread cancer, or in an earlier stage of treatment where the cancer came back during or within 12 months of finishing that therapy
• People with triple negative breast cancer, where no specific prior cancer treatment is required before joining
• People who have imaging evidence of one or more spots of cancer that have spread to the brain (brain metastases)
• People whose brain metastases are either new, or have grown or returned after previous treatment, with at least one spot larger than 5mm
• People whose brain metastases are not causing symptoms and whose neurological condition is stable (if they have not had previous radiation to the brain)
• People who have imaging evidence of at least one measurable area of cancer outside the brain that can be reached with a biopsy needle
• People who are willing to have a research biopsy of their tumour tissue
• People who are considered medically well enough to safely undergo a biopsy
• People whose tumour tissue shows abnormally active HER2 signalling, as measured by a specific laboratory test called the CELsignia test
• People who are expected by their doctor to be a candidate for systemic (whole-body) cancer treatment now or in the future
• People whose heart is pumping at 50% or greater efficiency, as measured before starting treatment
• People whose side effects from previous cancer treatments have largely resolved (to a mild level or better)
• People with adequate bone marrow, liver, kidney, and blood clotting function based on blood tests
• People who are post-menopausal, have been surgically sterilised, or are willing to use reliable contraception during the study and for 180 days after stopping treatment; people who can father children must be willing to use highly effective contraception for at least 90 days after their last dose
• People who are able to understand the nature of the study and provide signed informed consent
• People who have had no major surgery in the 10 days before registering for the treatment phase
• People who have waited a sufficient period since their last cancer treatment before registering (specific waiting periods apply depending on the type of treatment received — confirm with trial site)
• People with an ECOG performance status of 0–2, meaning they are able to carry out most daily activities with at most some limitation (confirm with trial site)

Who may not be able to join:

• People who have already received the chemotherapy drug capecitabine for breast cancer that has spread (metastatic setting)
• People who received capecitabine only around the time of their original surgery, if their cancer came back while taking it or within 180 days of finishing it
• People with a history of another cancer, unless it was a non-melanoma skin cancer that was adequately treated, a cervical cancer treated successfully while still localised, or another solid cancer that was fully treated with no signs of return in the last 2 years
• People who have a condition affecting their digestive system that prevents them from absorbing tablets or oral medication
• People with a known allergy or sensitivity to the study drugs or their ingredients
• People who are pregnant or breastfeeding
• People with known or suspected spread of cancer to the lining of the brain or spinal cord (leptomeningeal disease)
• People with known bleeding or clotting problems, or who are taking blood-thinning medications in a way that could significantly raise the risk of bleeding during a biopsy (management options may be discussed with the trial site)
• People currently taking certain medications that strongly affect how the liver processes drugs (known as strong or moderate CYP3A4 inhibitors or inducers), unless those medications can be stopped at least 14 days before registering
• People with uncontrolled ongoing health conditions that could affect their ability to participate in the study
• People with inflammatory bowel disease where diarrhoea is a major problem
• People whose CELsignia test shows normal or inconclusive HER2 signalling in their tumour
• People who have had whole-brain radiation therapy within the past three months
• People with a resting blood pressure above 160 (top number) and/or 110 (bottom number) mmHg, or poorly controlled high blood pressure
• People with serious heart conditions, including significant heart failure, uncontrolled irregular heart rhythms, unstable chest pain, or significant heart valve disease
• People diagnosed with a blood clot in the lungs or legs within the previous three months

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