Phase 3 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 are willing to take part voluntarily and sign a consent form
• People aged 18 years or older
• People who have been diagnosed with breast cancer that cannot be surgically removed and has either spread locally or to other parts of the body, confirmed by laboratory testing of tissue
• People whose breast cancer has tested positive for HER2 (a specific protein on cancer cells), based on specific laboratory test results (IHC 3+, or IHC 2+ with a positive follow-up test called ISH)
• People who have already received treatment with trastuzumab (a HER2-targeting drug) and taxanes (a type of chemotherapy) for their advanced breast cancer
• People with a general health and activity level rated between 0 and 2 on the ECOG scale, meaning they are able to care for themselves and are not confined to bed (confirm with trial site)
• People whose liver, kidneys, and other major organs are functioning well enough as determined by the trial team
• People with a life expectancy of at least 3 months
• People of childbearing potential (both female and male) who agree to use effective contraception throughout the entire study

Who may not be able to join:

• People who have previously been treated with a type of drug called a HER2-targeted antibody-drug conjugate (ADC) that carries a tubulin inhibitor (confirm with trial site)
• People who have had another type of cancer within the past three years
• People who had uncontrolled fluid build-up in body cavities in the 14 days before joining the study, particularly if it needed frequent draining or medical treatment
• People who have a known reason they cannot take the study drugs
• People who have not yet recovered from side effects of previous cancer treatments (side effects must have improved to a mild or baseline level)
• People who experienced moderate or severe nerve damage in the hands or feet (peripheral neuropathy, Grade 2 or higher) during previous cancer treatment
• People who received certain cancer treatments too recently before joining the study — including immunotherapy or biological therapy within the past 4 weeks, or chemotherapy, hormone therapy, or targeted therapy within the past 2 weeks
• People who had major surgery (not including needle biopsies) within 28 days before joining the study
• People who have untreated or unstable cancer that has spread to the brain, spinal cord, or the lining around the brain and spinal cord
• People whose previous treatment with a type of chemotherapy called anthracyclines has already reached the maximum recommended lifetime dose
• People with a history of the heart's pumping function dropping below 40%, or a history of symptomatic heart failure
• People with serious or uncontrolled heart or cardiovascular disease
• People with a history of lung inflammation (not caused by infection) that required treatment with steroid medication
• People who currently have an eye condition that requires medication or surgery, or who are unwilling to stop wearing contact lenses during the study
• People who had active infections requiring intravenous antibiotics, antiviral, or antifungal treatment within 14 days before joining the study
• People with any other circumstances that the trial team determines could interfere with the study or may not be in the person's best interest

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