Phase 1 Breast 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:

• Adults aged 18 or older who have been diagnosed with a specific type of breast cancer called infiltrating ductal carcinoma, confirmed by a tissue test (biopsy).
• People whose breast cancer has been staged at Stage 1A or higher, but without cancer that has spread to distant parts of the body, based on scans and imaging done before surgery.
• People whose blood cell counts and blood health meet certain minimum levels — including white blood cells, neutrophils, platelets, and haemoglobin — as measured by blood tests (confirm with trial site for exact values).
• People whose liver enzyme levels (ALT and AST) are within an acceptable range, no more than 10% above the normal upper limit.
• People who are physically well enough to carry out daily activities with no or minimal limitations, as measured by a standard scale called the WHO Performance Status score of 0 or 1.
• People who have not received chemotherapy or started new hormone therapy for their cancer before joining the trial.
• People who are able to become pregnant must have had a negative pregnancy test within 72 hours before starting the first treatment cycle.
• People whose hormone receptor status (ER, PR, HER2) and menopausal status do not need to meet specific requirements for this trial.
• People, or their legal representatives, who are willing and able to give written informed consent to participate.

Who may not be able to join:

• People under 18 years of age.
• People with serious dysfunction of a major organ.
• People with a WHO Performance Status score above 1, meaning their daily functioning is significantly affected by their health.
• People who have previously received chemotherapy for cancer.
• People whose cancer is at Stage IV (meaning it has spread to distant parts of the body).
• People who have breast cancer that has spread to the brain or central nervous system and is causing symptoms.
• People who have had another invasive cancer diagnosed within the last 3 years.
• People who have experienced a loss of consciousness or a mini-stroke (transient ischemic attack) within the 12 months before the trial would begin.
• People with a known active HIV, Hepatitis B, or Hepatitis C infection.
• People with any other condition that the trial doctor believes would make participation unsuitable (confirm with trial site).

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