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 aged 18 to 70 years old, any gender
• People whose general health and ability to carry out daily activities falls within an accepted range on a standard medical scale (ECOG score 0–2) (confirm with trial site)
• People who have been diagnosed through lab testing with a type of breast cancer that is both hormone receptor-negative (ER and PR negative) and HER2-negative, and whose cancer has come back or spread to other parts of the body in a way that cannot be fully treated with surgery or radiation
• People who have either never received platinum-based chemotherapy drugs, or who have received only one platinum-based treatment regimen (cisplatin or carboplatin) and whose cancer did not progress during at least 4 cycles of that treatment, with progression occurring more than 3 months after the last platinum dose
• People with an expected survival of at least 8 weeks
• People who have at least one untreated brain tumour lesion measuring 1.0 cm or more confirmed by MRI — or, if brain lesions were previously treated with radiation, MRI evidence showing the cancer has continued to grow after that radiation
• People whose neurological symptoms have been stable for at least 1 week before enrolling, and whose medications for brain swelling or seizures (such as mannitol, steroids, or anticonvulsants) have been at a stable dose for at least one week without needing to be increased
• People able to provide at least 10 tumour tissue samples (from the original tumour or a spread site, preferably from a brain lesion) for research testing before treatment begins
• People whose blood counts, organ function, heart function, and other lab results meet the required levels set out in the trial protocol (confirm with trial site)
• People who are willing to take part voluntarily, sign a consent form, follow the trial requirements, and attend follow-up appointments

Who may not be able to join:

• People whose cancer has spread to the lining around the brain or spinal cord (leptomeningeal metastases), or who have cyst-like tumour lesions in the brain, confirmed by MRI or spinal fluid testing
• People with uncontrolled fluid build-up in body cavities, such as large amounts of fluid around the lungs or in the abdomen, that cannot be managed by drainage or other methods
• People who have received whole-brain radiation, chemotherapy, or brain surgery within 2 weeks before starting the trial drug, or hormone therapy within 1 week before starting
• People who have previously used bevacizumab or PD-1/PD-L1 immunotherapy drugs, unless specific conditions apply (confirm with trial site)
• People who have taken part in another drug clinical trial within 2 weeks before enrolling
• People currently receiving any other cancer treatment for any tumour
• People with a history of another cancer in the past 5 years, except for certain cured skin cancers or early-stage cervical cancer that has been fully treated
• People with a history of significant heart problems, including heart rhythm disorders requiring medication, heart attack, heart failure, or other heart conditions the doctor considers unsuitable
• People with a known allergy to any ingredient in the trial medications
• People with a history of immune system disorders, a positive HIV test, active hepatitis B or C, other immune deficiency conditions, or a history of organ transplant
• People with a history of certain neurological or psychiatric conditions, including epilepsy or dementia
• People who are pregnant, breastfeeding, have a positive pregnancy test at the start of the trial, or are not willing to use effective contraception throughout the study
• People with serious other health conditions that the doctor believes could put them at risk or prevent them from completing the study, such as uncontrolled high blood pressure, severe diabetes, active infection, or thyroid disease
• People considered unsuitable for any other reason, at the doctor's judgement

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