Phase 2 Brain 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 are 18 years old or older
• You have been diagnosed with advanced breast cancer that has been confirmed by lab testing to be HER2-positive or HER2-low
• You have at least one measurable tumor in the brain that has not yet been treated locally (for example, not yet treated with radiation or surgery)
• You have not had any previous radiation to the brain, and either there is no urgent need for immediate local brain treatment, or you have chosen not to have local treatment
• It has been more than 2 weeks since your last cancer treatment; if you had brain surgery, you may still be eligible as long as you have not had radiation afterward; if your cancer is HER2-low, your brain metastases must not have been treated with any systemic (whole-body) therapy
• You have previously received HER2-targeted therapy, hormone therapy, or chemotherapy (these are allowed)
• Your doctors expect you to live at least 6 months
• Your major organs (such as heart, liver, and kidneys) are functioning well enough

Who may not be able to join:

• Cancer has spread to the lining of the brain or spinal cord (leptomeningeal disease)
• You have serious brain complications that require emergency brain surgery (such as tumor removal or a shunt), or your brain metastasis symptoms are not controlled
• You have previously been treated with a drug called trastuzumab deruxtecan (T-DXd/DS-8201a) or any similar type of drug (called an antibody-drug conjugate) that works in the same way
• Depending on which treatment group (arm) you would be assigned to, you may not be eligible if you have previously stopped responding to certain specific therapies, including HER2 tyrosine kinase inhibitors, bevacizumab, or PD-1/PD-L1 immunotherapy (confirm with trial site)
• You are currently receiving other cancer treatments outside of this study
• You have had cancer treatments such as radiation, chemotherapy, surgery, targeted therapy, or immunotherapy within the past 2 weeks, or hormone therapy within the past 1 week
• You have taken part in another clinical drug trial within the past 4 weeks
• You have a history of significant lung disease
• You have been diagnosed with another cancer in the past 5 years, unless it was an early-stage, fully cured cervical cancer, or a certain type of cured skin cancer (basal cell or squamous cell)
• You have another serious health condition that the researchers believe could put you at risk or prevent you from completing the study, such as severe high blood pressure, severe diabetes, or an active infection
• The trial doctors have any other concerns that make you unsuitable for this study (confirm with trial site)

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