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:

• People aged 18 or older
• People who have been diagnosed with invasive breast cancer that has spread to other parts of the body (metastatic), confirmed by tissue or cell testing, or by physical or imaging examination
• People whose breast cancer has been confirmed as "triple negative" breast cancer (meaning the cancer tests negative for HER2, estrogen receptor, and progesterone receptor) based on recent biopsy results
• People who have either newly diagnosed cancer spread to the brain, or whose brain metastases have come back or grown after previous local treatment
• People who have at least one measurable brain tumour that can be seen clearly on a brain scan, and whose brain-related symptoms are either absent or well controlled without needing urgent radiation treatment
• People who have previously been treated with at least one taxane (a type of chemotherapy) and/or one anthracycline (another type of chemotherapy), whether as part of earlier treatment or treatment for spread of the cancer
• People whose cancer came back more than one year after stopping certain prior treatments (Utidelone and/or Capecitabine), or who stopped those treatments for reasons other than the cancer getting worse
• People with a general health/activity level score of 0–2 on the ECOG scale (a medical measure of how well a person can carry out daily activities), and a life expectancy of more than 12 weeks
• People with adequately functioning blood, liver, and kidney results within one week before joining, meeting specific laboratory thresholds (confirm details with trial site)
• People with little or no nerve damage (below a certain severity level) in the four weeks before joining
• People with no major organ problems and no significant heart disease
• People who are able and willing to use appropriate contraception before and during the study, if there is any possibility of pregnancy

Who may not be able to join:

• People whose cancer has spread widely through the lining of the brain and spinal cord, and whose swelling is not responding to steroid treatment, or who urgently need radiation therapy
• People who received chemotherapy, major surgery, targeted therapy, or immunotherapy within 2 weeks before joining (or within 6 weeks for certain specific chemotherapy types), or endocrine (hormone-blocking) therapy within 1 week before joining
• People who received an investigational (unlisted trial) drug within 4 weeks before joining
• People who have previously had a severe (grade 3 or 4) allergic reaction to Utidelone or Capecitabine
• People who are unable to swallow, or who have chronic diarrhoea or bowel obstruction that could affect how the study drugs are absorbed
• People who have a known reason they cannot safely have a gadolinium-enhanced MRI scan (such as a pacemaker, metal fragments, or eye foreign bodies)
• People who have had another cancer diagnosis in the past 3 years, except for certain fully treated cancers such as early-stage cervical, skin, or thyroid cancers
• People who have had more than two seizures in the four weeks before joining
• People with poorly controlled high blood pressure, or a history of hypertensive crisis or hypertensive brain complications
• People who have had a significant bleed in the brain or spinal cord area within the past 12 months
• People with serious or uncontrolled illnesses, including active viral infections (such as HIV or active hepatitis B or C), or serious heart conditions such as recent heart attack, uncontrolled irregular heartbeat, heart failure, or poor heart pumping function
• People who have had coughing up blood in the 6 months before joining, or who have signs of a bleeding disorder in the past month
• People currently taking full-dose blood-thinning medication (such as warfarin) or high-dose aspirin
• People who are expected to need major surgery, an open biopsy, or who have experienced a major injury within 28 days before or during the study
• People with a history of abnormal connections or holes in the abdomen or bowel in the past 6 months, or who have wounds that have not healed, active ulcers, or untreated fractures
• People who are pregnant or breastfeeding
• People with a history of substance misuse that cannot be resolved, or people with a mental health disorder
• People with known allergies to the components of the study drugs
• People with a history of immune deficiency conditions (including HIV), hepatitis C, other immune conditions, or a history of organ transplantation
• People who have received a live vaccine within 28 days before the study starts, or who are expected to receive one during the study
• People whose overall condition the trial doctor considers unsuitable for participation for any other reason

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