Phase 3 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:

• People who have read and understood what the study involves, and have signed the consent form
• People aged 18 or older at the time of signing the consent form, of any gender
• People who have been confirmed through tissue testing to have breast cancer that has spread to other parts of the body or cannot be surgically removed (advanced or metastatic)
• People whose cancer has been confirmed by the trial's central laboratory to be HER2-positive (meeting specific testing thresholds defined by the trial)
• People whose cancer may be either hormone receptor positive or negative, as confirmed by the trial's central laboratory
• People who have not previously received chemotherapy or HER2-targeted treatment for their advanced or metastatic breast cancer (one prior hormonal therapy is allowed)
• People who have at least one area of cancer that can be measured using standard imaging criteria (RECIST v1.1), as assessed by the trial's central imaging team
• People whose general physical functioning, as rated on a standard medical scale, falls within an acceptable range (score of 0 or 1) within 7 days before starting the study treatment
• People with a life expectancy of at least 12 weeks
• People whose heart, liver, kidneys, and other major organs are functioning at an adequate level

Who may not be able to join:

• People who have had a second, separate cancer diagnosis within the 3 years before signing the consent form
• People who have previously received a high cumulative dose of the chemotherapy drug doxorubicin (above 360 mg/m², or an equivalent amount of a similar drug)
• People who have previously been treated with a type of targeted drug delivery therapy (called an antibody-drug conjugate, or ADC) that contains a specific class of anti-cancer agent known as a topoisomerase I inhibitor
• People with heart or blood vessel disease that is not well controlled or is considered significant
• People who have had a stroke or similar brain blood vessel event within 6 months before starting the study treatment
• People who have or are suspected to have a lung condition involving inflammation or scarring (such as interstitial lung disease or pneumonitis), or other significant lung illness
• People who have an active infection at the time of joining
• People who have cancer that is pressing on the spinal cord, or who have brain or nervous system metastases that are causing symptoms
• People who still have side effects from previous cancer treatment that have not resolved to a mild or baseline level (hair loss is an exception to this)
• People with active tuberculosis
• People who have received a live vaccine within 30 days before starting the study treatment
• People with a known history of severe allergic reactions to large-molecule protein-based medicines, or known allergies to any ingredient in the study drugs
• People with a known history of misuse of or addiction to mind-altering substances
• People who are pregnant or currently breastfeeding

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