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:

• Women between 18 and 70 years old (age calculated on the day consent is signed)
• People whose general health and ability to carry out daily activities meets a minimum score on a standard medical scale, or who score slightly below that threshold only because of neurological symptoms (confirm with trial site)
• People whose breast cancer has been confirmed by the pathology department at Jiangsu Provincial Hospital as HER2-negative, based on specific laboratory testing results
• People who have brain metastases (cancer that has spread to the brain) confirmed by a contrast-enhanced MRI scan, with at least one measurable affected area in the brain
• People who have had prior cancer treatment (other than treatment specifically aimed at brain metastases) must have finished that treatment at least 2 weeks before joining, and any side effects from it must have largely resolved; certain supportive medications such as steroids, mannitol, and bone-strengthening drugs are allowed during the trial, provided steroid doses have been stable for at least one week before joining
• People with a life expectancy of at least 3 months
• People whose blood counts meet minimum levels without having needed a transfusion or blood-stimulating medication in the 14 days before testing (confirm with trial site)
• People whose liver and kidney function blood tests fall within acceptable ranges as defined by the trial (confirm with trial site)
• Women who could become pregnant must either be surgically unable to have children, be postmenopausal, or agree to use reliable contraception during the trial and for 6 months after the last dose; a negative pregnancy blood test within 7 days before joining is also required for women who are not postmenopausal or surgically sterile
• People who are not currently breastfeeding
• People who agree to take part voluntarily and sign a written consent form

Who may not be able to join:

• People with widespread cancer spread to the lining of the brain and spinal cord, or brain metastases that are bleeding
• People with seizures that are not well controlled
• People who have difficulty swallowing, persistent diarrhoea, or a bowel blockage that would significantly affect their ability to take oral medication
• People with a known allergy to anlotinib or any ingredient in the study drug
• People with a history of immune system deficiency, HIV, other immune conditions, or a history of organ transplant
• People with significant heart problems, including unstable chest pain, moderate-to-severe heart failure, uncontrolled serious irregular heartbeat, or a heart attack within the 6 months before joining
• People with an active or uncontrolled infection requiring treatment through a drip or injection within the 2 weeks before joining (minor urinary or upper respiratory infections are generally not excluded — confirm with trial site)
• People with a history of another cancer within the past 5 years or a current second cancer, except for certain fully treated skin cancers or early-stage cervical changes
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after finishing treatment
• People (or their male partners) who are unwilling to use reliable contraception during treatment and for 6 months after finishing
• People who are unable to have a contrast-enhanced MRI scan
• People who have previously received a particular type of targeted anti-cancer drug (anti-angiogenic TKI therapy) and whose brain cancer progressed while on or after that drug; people who received this type of drug without their disease progressing may still be eligible (confirm with trial site)
• People who are unwilling or unable to attend the follow-up visits required by the trial
• People who the trial doctor believes, for any other reason, would not be able to follow the trial requirements or whose participation could affect the reliability of the results

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