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:

• Adults aged 18 or older at the time of signing the consent form, of any gender
• People with confirmed metastatic solid tumours (cancer that has spread to other parts of the body), whether newly diagnosed or previously treated, including those who have had multiple rounds of treatment
• People with metastatic breast cancer that is hormone receptor positive/HER2 negative, triple-negative, or HER2 positive — including cases where HER2 status may be confirmed during the study — or people with other types of metastatic solid tumours
• People who have at least one tumour lesion outside the liver, measuring 15mm or larger, that shows up on specific scans (a combined PET and CT scan with contrast dye) and is in a location where a biopsy can be performed
• People who are willing to have at least one tumour biopsy as part of the study
• People who are able and willing to use effective contraception during the study (applies to men who are able to father children and women who are able to become pregnant)
• People with a good general level of physical functioning, as measured by a standard medical scale (ECOG performance status 0 to 1) (confirm with trial site)
• People who are able and willing to provide written consent to participate

Who may not be able to join:

• People whose cancer has not spread beyond the original tumour site (non-metastatic cancer)
• People who are not willing to have a tumour biopsy as part of the study — note that a biopsy done before the study screening period will not be accepted
• People who had the required PET/CT scan before the screening period and are not willing to have it repeated
• People whose scan results show that none of their tumour lesions can be safely biopsied due to location, tissue type, or risk of serious complications
• People whose cancer has spread only to the brain and liver, with no other sites of spread
• People with a life expectancy of less than 3 months
• People who are pregnant or breastfeeding
• People with poor organ function, indicated by abnormal blood test results, including: severely reduced kidney function, low white blood cell count, elevated bilirubin levels (unless a specific liver condition called Gilbert's syndrome has been diagnosed), or significantly elevated liver enzyme levels
• People with a known allergy or sensitivity to any component of the investigational medicine or its packaging
• People at increased risk of bleeding or other complications from biopsies — for example, those on blood-thinning medication that cannot be safely stopped temporarily
• People with a known allergy or sensitivity to iodinated contrast dye used in CT scans, where this cannot be managed with preventive measures
• People who are unable to undergo PET/CT scanning for any reason, including body size or claustrophobia
• People with any condition that, in the opinion of the study doctor, may significantly affect their ability to follow the study requirements, including psychological, social, or geographical factors

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