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:

• You have been diagnosed with breast cancer that has spread or cannot be removed by surgery, and your cancer has been confirmed as HER2-positive by a central laboratory.
• Your cancer has at least one tumor that can be measured by scans (required for the first part of the trial; the second part may also accept those without measurable tumors).
• You have cancer that has spread to the brain or the lining of the brain — whether previously treated or untreated, stable or growing.
• You have already received at least one treatment targeting HER2 for your advanced or spread cancer.
• You have previously received a type of targeted drug called an antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan or trastuzumab emtansine; if you haven't, you may still be considered if these treatments are not available where you live or if there is a documented medical reason you cannot receive them (confirm with trial site).
• You previously took a specific type of drug called a tyrosine kinase inhibitor (TKI), but only as an early-stage treatment and finishing more than 12 months before your cancer became advanced — you must not have taken a TKI for advanced or spread cancer.
• Your liver, kidneys, and bone marrow are functioning well enough to meet the trial's requirements (confirm with trial site).
• You are generally well enough to carry out daily activities with little or no limitation (measured by a standard scale called ECOG 0 or 1).
• Your heart is pumping at least 50% of its capacity, as measured by a heart scan.

Who may not be able to join:

• You are currently receiving another cancer treatment, or have received an experimental treatment within the last 28 days before starting this trial.
• You have active or untreated hepatitis B, hepatitis C, or a long-term liver disease.
• You have a significant heart condition, such as moderate-to-severe heart failure, a recent heart attack or heart procedure, a serious irregular heartbeat, certain abnormal heart rhythm readings, poorly controlled high blood pressure, blocked arteries in the legs, a weakened heart muscle, or unstable chest pain.
• You have significantly abnormal levels of certain minerals in your blood (such as potassium, magnesium, or calcium), or a family history of sudden unexplained death or a heart rhythm condition called long QT syndrome.
• You are currently taking certain medications or herbal remedies that strongly affect how the body processes drugs (specifically those that strongly interact with enzymes called CYP3A4 or CYP2C8), or you are taking a type of blood thinner called a coumarin-based anticoagulant (such as warfarin).

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