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 been diagnosed with breast cancer that has spread to other parts of the body, and whose tumour has tested HER2-negative (confirmed by a laboratory test on a tissue sample).
• People who have at least one measurable area of cancer in the brain, measuring 1.0 cm or larger, seen on a contrast brain MRI scan done during screening.
• People aged 18 or older, of any gender.
• People who are relatively physically well and able to carry out daily activities, as measured by a standard medical score called ECOG Performance Status 0 or 1 (confirm with trial site).
• People who are expected to live for at least 3 months.
• People whose blood cell counts are within an acceptable range (confirm with trial site).
• People whose liver and kidney are functioning well enough, as confirmed by blood tests.
• People who have had no more than 3 previous chemotherapy treatments for advanced or metastatic breast cancer.
• Women who could become pregnant must be using an effective form of contraception for at least 4 weeks before the trial drug is given, throughout the trial, and for 6 months after the last dose. Male participants, or their partners, must also use effective contraception during the same timeframes.
• People who are able to attend the required study visits and who are able to sign an informed consent form.

Who may not be able to join:

• People whose cancer has spread to the lining of the brain or spinal cord (leptomeningeal metastasis), confirmed by MRI or fluid testing.
• People who have a brain lesion that doctors believe needs to be treated urgently, or one that is in a location where swelling could be dangerous (such as the brain stem).
• People who are having poorly controlled seizures (more than once a week), or whose brain metastases are causing worsening neurological symptoms despite treatment directed at the brain.
• People who have had bleeding in the brain within the 3 months before starting the study treatment.
• People who have had coughing up of blood within 6 months before study treatment, or any bleeding disorder or active bleeding within 4 weeks before study treatment.
• People who have had major surgery within 4 weeks before study treatment, or who have not fully recovered from a previous surgery.
• People who have received any anti-cancer treatment (including hormone therapy, chemotherapy, radiotherapy, targeted therapy, immunotherapy, or similar) within 2 weeks before the first dose of the trial drug.
• People who still have significant side effects from previous cancer treatments (not including hair loss) that have not returned to a mild level or to their pre-treatment baseline.
• People who have nerve damage (neuropathy) rated above grade 1 in severity (confirm with trial site).
• People who are known to be allergic to any ingredient in the trial drug.
• People who are known to have a deficiency of an enzyme called dihydropyrimidine dehydrogenase (DPD), which affects how certain drugs are processed by the body.
• For the combination treatment group only: people who previously received capecitabine and either did not respond to it (cancer progressed), or received it within 6 months before starting the trial.
• People who are currently pregnant or breastfeeding.
• People who have had another cancer in the past 5 years, with some exceptions such as certain skin cancers, cervical carcinoma in situ, or papillary thyroid cancer that has been treated and is no longer active.
• People who are currently participating in another interventional clinical trial or receiving another experimental treatment.
• People with known active or uncontrolled hepatitis B, active syphilis, or HIV that is not well managed; or who test positive for hepatitis B markers during screening.
• People with a history of severe or poorly controlled health conditions (confirm with trial site).
• People who have autoimmune diseases that require treatment with steroid medications taken throughout the body (systemic glucocorticoids).
• People who are unable to have a contrast-enhanced brain MRI, or who have a known reason they cannot receive MRI contrast dye (such as a cardiac pacemaker, metal fragments, or a foreign body in the eye).
• People with other serious medical conditions or abnormal test results that, in the treating doctor's judgement, make participation in this study inappropriate.

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