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:

• Adults aged 18 or older at the time of giving consent
• People with HER2-positive metastatic breast cancer that has spread to the brain, with at least one brain tumour larger than 5mm that is new or growing (previous local treatment to other brain lesions is allowed)
• People who have received at least one standard treatment for metastatic breast cancer before joining the trial
• People who have previously been treated with both T-DXd and Tucatinib — though this requirement may be waived if those treatments could not be given due to allergies or side effects that made them intolerable
• People who have waited long enough since their last treatment before enrolling: more than 4 weeks after major surgery; more than 1 week after brain radiation; appropriate waiting periods after chemotherapy or other cancer therapies depending on the type (confirm with trial site for specifics); hormone therapies such as aromatase inhibitors, tamoxifen, or fulvestrant do not require a waiting period but should be stopped before trial treatment begins
• People whose liver, kidney, and bone marrow are functioning well enough, as confirmed by blood tests meeting specific thresholds set by the trial (confirm with trial site for details)
• People whose heart is pumping at 50% or greater efficiency, as measured by a heart scan
• Women who could become pregnant must have a negative pregnancy test at the screening stage
• Women who could become pregnant and men must be willing to either avoid heterosexual intercourse or use highly effective contraception during the trial
• People whose cancer has spread only to the brain are still eligible — the cancer does not need to have spread to other parts of the body
• People with a limited, focal form of cancer affecting the lining around the brain (leptomeningeal disease) may be considered at the investigator's discretion
• People with a general health and activity level rated 0, 1, or 2 on the ECOG performance scale (a scale measuring how much a person's cancer affects daily activities — 0 meaning fully active, 2 meaning able to care for oneself but unable to work)
• People who are willing and able to sign a written consent form before enrolling

Who may not be able to join:

• People who have bleeding in the brain, signs that the brain is under dangerous pressure, or who need urgent local treatment to brain tumours, or who require increasing doses of steroids to manage brain symptoms
• People with moderate or severe nerve damage causing numbness, tingling, or pain in the hands or feet (grade 2 or higher peripheral neuropathy)
• People with widespread and symptomatic cancer spread to the lining around the brain and spinal cord (diffuse leptomeningeal carcinomatosis)
• People with a significantly prolonged heart electrical interval (QTcF greater than 450), heart failure, or poorly controlled high blood pressure
• People with clinically significant heart or lung disease
• People who have had inflammation of the pancreas (pancreatitis) within the 6 months before starting the trial
• People with serious active infections, including active tuberculosis, active hepatitis B, active hepatitis C, or active HIV — though people with certain resolved or well-controlled forms of these infections may still be eligible (confirm with trial site)
• People who are unable to have an MRI scan of the brain for any reason
• People currently taking certain strong medications that significantly affect how the body processes drugs (strong CYP3A4 inhibitors within 5 half-lives of trial treatment, or certain other medications that cannot safely be taken alongside the trial treatment) — confirm specific medications with the trial site
• People who are currently taking more than 2mg per day of dexamethasone (or an equivalent steroid) to manage brain tumour symptoms
• People with cancer that has spread widely to the lining of the brain and spinal cord, or with cancer cells found in the fluid around the brain and spinal cord (though certain limited, distinct tumours on the outer brain lining are allowed)
• People with poorly controlled seizures that continue despite appropriate anti-seizure medication
• People with an active infection currently requiring intravenous (drip) antibiotics or other intravenous treatments
• People who are pregnant or breastfeeding (breast milk cannot be stored for later use during the trial)
• People who have had or currently have another cancer in the past 5 years that could interfere with assessing the safety or effectiveness of this trial, as determined by the treating doctor
• People who have taken part in another clinical trial and received an experimental treatment within 30 days before starting this trial

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