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 have given written consent to take part, or where someone they trust has confirmed their consent in writing if they are physically unable to do so themselves
• People aged 18 or older
• People who have been diagnosed with breast cancer that has spread to other parts of the body (metastatic), confirmed by tissue testing
• People whose breast cancer has been confirmed by laboratory testing to be HER2-positive (any hormone receptor status is allowed)
• People who have confirmed spread of cancer to the lining around the brain and spinal cord (leptomeningeal metastases), shown either on an MRI scan or by the presence of cancer cells in spinal fluid collected within 28 days before joining
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to capable of limited self-care (confirm with trial site)
• People with a life expectancy of at least 2 months
• People who have been on a stable dose of steroids for at least 5 days before registering
• People who have had local treatment (such as surgery or radiation) for brain or leptomeningeal metastases, provided it was completed at least 2 weeks but no more than 8 weeks before joining, and no further immediate local treatment is needed
• People whose blood counts are within acceptable ranges on testing done within 14 days before joining (adequate levels of white blood cells, platelets, and haemoglobin)
• People whose liver function test results are within acceptable ranges on testing done within 14 days before joining
• People whose kidneys are functioning at an adequate level, based on a calculation done within 14 days before joining
• People whose heart is functioning adequately, including acceptable heart rhythm readings on an ECG, a normal heart pumping strength of at least 55%, and no history of certain serious heart rhythm problems
• People whose side effects from previous cancer treatments or surgery have resolved to a mild or absent level (with the exception of hair loss or other effects considered low risk by the treating doctor)
• Women who could become pregnant and who have had a negative pregnancy test within 14 days before joining
• Women who could become pregnant, and male participants, who agree to use effective contraception throughout the trial and for up to 7 months after finishing treatment — noting that hormonal contraceptives are not permitted for people with hormone receptor-positive cancer
• People who are covered by a social security system or equivalent (confirm with trial site — this criterion may apply in specific countries)
• People who are willing and able to follow all trial requirements, including visits, tests, and follow-up appointments

Who may not be able to join:

• People who have recently taken certain medications that strongly affect how the body processes drugs (specific enzyme inhibitors or inducers — confirm with trial site on timing and specific drugs)
• People who have previously been treated with tucatinib or capecitabine
• People with severely low white blood cell or platelet counts, severe liver problems, or severely reduced kidney function
• People currently taking or who have recently taken a medication called brivudine
• People taking blood-thinning or anti-clotting medications for a blood coagulation condition
• People with serious pre-existing brain blood vessel conditions such as stroke, bleeding in the brain, or uncontrolled pressure in the brain caused by brain metastases
• People who have a certain type of brain fluid drainage device (shunt), unless it has a specific on/off valve and the person's condition allows it to remain switched off for 6 hours after each injection of trastuzumab
• People who have a known history of HIV or AIDS
• People who carry hepatitis B or hepatitis C, or who have another known long-term liver disease
• People with uncontrolled high blood pressure
• People with an uncontrolled infection
• People with severe breathlessness at rest due to advanced cancer, or who require supplemental oxygen
• Women who are pregnant or breastfeeding
• People with a known history of severe allergic reaction to tucatinib or closely related compounds
• People with a known history of severe allergic reaction to trastuzumab or to murine (mouse-derived) proteins
• People with a known history of severe allergic reaction to capecitabine or fluorouracil
• People with a known complete deficiency of an enzyme called DPD, which affects how certain chemotherapy drugs are processed by the body
• People who are unable to swallow tablets, or who have a significant digestive condition that would prevent medications from being properly absorbed
• People with a history of another cancer in the past 5 years, other than certain skin cancers or cervical carcinoma in situ
• People who are under legal guardianship or protective custody
• People who have participated in another treatment trial within the 30 days before starting this trial
• People with another illness that requires hospitalisation or is not compatible with the trial treatment, and people who are unable or unwilling to meet trial obligations for geographic, social, physical, or comprehension-related reasons

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