Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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, of any gender
• People whose general health and ability to carry out daily activities falls within a certain range, as assessed by a standard medical scale (called ECOG Performance Status 0–2, meaning fully active to capable of limited self-care — confirm with trial site)
• People who have been confirmed through tissue or cell testing to have breast cancer that is both hormone receptor-negative (ER and PR negative) and HER2-negative, with cancer that has spread to other parts of the body and cannot be treated with surgery or radiation aimed at curing the disease
• People who have brain metastases (cancer that has spread to the brain) confirmed by MRI, with at least one affected area in the brain measuring 1.0 cm or more in its longest dimension that has not previously been treated with radiation; or, if prior radiation was given, where MRI has confirmed the cancer has continued to grow after that radiation
• People whose treating doctor considers local treatment (such as surgery or radiation to the brain) unnecessary at this time
• People with a life expectancy of at least 3 months
• People who, if receiving treatments to manage brain swelling (such as a shunt, mannitol, hormones, or anti-seizure medication), have been on a stable dose of those medications for at least one week with no increase, and whose neurological symptoms have been stable for at least one week
• People whose blood, organ function, and heart test results meet specific medical thresholds set by the trial (confirm exact values with trial site)
• People who are willing to sign a consent form, follow the study requirements, and attend follow-up appointments

Who may not be able to join:

• People whose cancer has spread to the lining of the brain or spinal cord (called pial metastases), confirmed by MRI or spinal fluid testing
• People with large, uncontrollable fluid build-up in body cavities such as the chest or abdomen
• People who have received whole-brain radiation, chemotherapy, targeted therapy, immunotherapy, surgery, or hormone therapy within the 2 weeks before joining the trial
• People who have previously used bevacizumab or similar anti-blood-vessel-growth drugs, except in specific situations assessed by the treating doctor (confirm with trial site)
• People who have previously been treated with a class of drugs called topoisomerase I inhibitors, or any antibody-drug conjugate (ADC) treatments, regardless of what those treatments targeted
• People who have taken part in another clinical trial within 2 weeks before enrolling
• People who are taking strong medications that affect how the body processes a particular liver enzyme (CYP3A4), within the 4 weeks before the first dose
• People currently taking any other cancer-fighting medications at the same time
• People with a tendency to bleed, such as active gastrointestinal bleeding, an ongoing bleeding disorder, or problems with blood clotting
• People who have had another cancer within the past 5 years, other than certain cured skin cancers or cervical cancer in situ
• People with a history of, current diagnosis of, or suspected lung inflammation or scarring (interstitial lung disease or non-infectious pneumonia) requiring steroid treatment, or serious lung conditions including severe asthma, severe COPD, pulmonary embolism, or certain autoimmune or inflammatory conditions affecting the lungs; or people who have had an entire lung surgically removed
• People with a history of severe dry eye disease, serious eyelid gland conditions, or corneal disease that affects healing of the eye surface
• People who have had a serious infection requiring hospitalisation, sepsis, or severe pneumonia within 4 weeks before the first dose; or an active infection requiring antibiotic or antiviral treatment within 2 weeks before the first dose
• People with a history of heart conditions including arrhythmias needing treatment, heart attack, heart failure, or any other heart condition the doctor considers a concern
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People with immune system conditions including HIV, active hepatitis B or C, other immune deficiency diseases, or a history of organ transplantation
• People with a diagnosed neurological or psychiatric condition, including epilepsy or dementia
• People with other serious ongoing health conditions such as uncontrolled high blood pressure, uncontrolled diabetes, active infection, or thyroid disease not manageable with medication, if the treating doctor considers these a safety concern
• People who are pregnant or breastfeeding; or people of childbearing potential who test positive for pregnancy, or who are unwilling to use adequate contraception during the study
• People who, in the treating doctor's judgement, have any other condition that makes participation in the trial unsuitable

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