Phase 2 Breast 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 at least 18 years old at the time of signing the consent form
• People who are able to sign a written consent form (or have a legal guardian sign on their behalf) before any study procedures begin
• People with a general health and activity level rated as 0 or 1 on a standard oncology scale, meaning they are fully active or have minor restrictions but are still able to carry out light work (confirm with trial site)
• People who have a confirmed diagnosis of locally advanced or metastatic HER2-positive breast cancer, based on specific laboratory test results
• People who have previously received at least one HER2-targeted treatment for advanced or metastatic disease, or whose cancer came back within 6 months of finishing an earlier HER2-targeted treatment; prior use of the drug tucatinib in the metastatic setting is also allowed
• People whose cancer has at least one area that can be measured using standard imaging criteria
• Women who could become pregnant must use adequate contraception from screening until 6 months after the last dose, must not be breastfeeding, and must have a negative pregnancy test before starting — or must have evidence of not being able to become pregnant (such as being post-menopausal or having had certain surgical procedures)
• People of any gender whose partner could become pregnant must use two forms of contraception (including one barrier method) during the study and for 6 months after the last dose; male participants must also not donate sperm during this time
• People whose blood counts meet minimum levels: sufficient white blood cells, platelets, and haemoglobin (specific numbers will be checked by the trial site)
• People whose liver function test results are within acceptable ranges (specific values will be checked by the trial site; people with a condition called Gilbert's Syndrome may still be eligible — confirm with trial site)
• People whose kidneys are functioning at or above a minimum level (confirmed by a blood test at the trial site)
• People whose heart pumping function is at 50% or above, as measured by a heart scan
• People who, on a brain scan with contrast dye, either have no brain metastases, have small untreated brain metastases that do not need immediate treatment, or have previously treated brain metastases — with specific timing requirements if recent brain treatment has occurred (confirm with trial site)

Who may not be able to join:

• People who have received certain anti-cancer treatments — including chemotherapy, targeted therapies, biological agents, or hormonal therapies — within 21 days or 5 half-lives (whichever is shorter) before the first dose, or within at least 10 days of their last dose
• People who have ever received a type of chemotherapy called an anthracycline (such as doxorubicin or epirubicin) at any point in their treatment history
• People who have had major surgery within 28 days before the first dose (routine procedures to place a port or line for treatment are not included in this restriction)
• People who have had palliative radiation therapy within 14 days before the first dose
• People who have untreated brain lesions larger than 2.0 cm, unless specifically approved by the trial's medical oversight team
• People who are currently taking steroid medication (such as dexamethasone) at more than a low stable dose to manage brain metastasis symptoms (confirm with trial site for specific dose thresholds)
• People who have a brain lesion in a location where swelling or growth could be immediately dangerous, such as in the brain stem
• People with known or suspected spread of cancer to the lining of the brain or spinal cord (leptomeningeal disease)
• People with poorly controlled seizures lasting more than one week, or whose neurological condition is worsening due to brain metastases despite treatment
• People currently taking certain medications that strongly affect how the study drug is processed by the body (specific drug classes will be reviewed by the trial site)
• People who still have significant side effects from previous cancer treatments that have not resolved — with some exceptions for stable, well-managed lower-level side effects (confirm with trial site)
• Women who are pregnant, breastfeeding, or plan to become pregnant during the study or within 6 months after the last dose
• Men who plan to father a child during the study or within 6 months after the last dose
• People with active digestive system conditions that could affect how the study drug is absorbed, such as active ulcers, uncontrolled nausea or vomiting, significant diarrhoea, or malabsorption
• People with certain heart conditions, including a specific type of irregular heart rhythm on an ECG, significant problems with heart conduction or rhythm, heart failure of a certain severity within the past 6 months, or a heart pumping function below 50%
• People with severe or uncontrolled health conditions such as uncontrolled high blood pressure, uncontrolled diabetes, active bleeding disorders, or active infections including hepatitis B or C
• People with a known HIV infection
• People who have had another active invasive cancer within the past 3 years, with some exceptions for certain easily treated skin or cervical conditions
• People whose personal, social, psychological, or geographic circumstances would make it difficult to follow the study requirements and attend follow-up visits

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