Phase 3 Rare Disease 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:

• Your cancer must have been confirmed to have a specific gene change called "HER2 amplification" or a related activating mutation, identified through a type of advanced genetic testing.
• You must be 12 years of age or older.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining and agree to use at least one reliable form of contraception (such as the pill, an IUD, condom, implant, or abstinence) from your first treatment dose until seven months after your last dose.
• If you are a man whose partner could become pregnant, you must agree to use barrier contraception (such as a condom with spermicide) or abstinence from your first dose until seven months after your last dose, and avoid donating sperm during this time.
• You must be willing and able to have a fresh tissue biopsy (a small sample taken from a tumour) and blood samples taken for research purposes at the start of the trial.
• You must have adequate organ function (such as blood count and kidney/liver levels) as confirmed by blood tests before joining — this applies to both adults (18 and over) and younger patients (under 18).

Who may not be able to join:

• You have been diagnosed with HER2-positive early or metastatic breast cancer.
• You are a woman who is currently pregnant, breastfeeding, or planning to become pregnant during the trial or within seven months of your last dose.
• You have severe difficulty breathing at rest caused by your cancer, or you need supplementary oxygen.
• You have a known allergy or serious reaction to trastuzumab, pertuzumab, or any of their ingredients (confirm with trial site).
• You have received a live vaccine (such as certain flu, shingles, or MMR vaccines) within the 28 days before joining, or expect to need one during treatment or within six months after your last dose.
• You have significant pre-existing heart problems, such as uncontrolled chest pain, serious heart rhythm problems, severe heart failure, a heart pumping function below 55%, or you have had a stroke, mini-stroke (TIA), or heart attack within the three months before starting treatment.
• You have previously been treated with a drug from the same category as trastuzumab or pertuzumab, unless your genetic test results suggest your cancer may still respond to these drugs (confirm with trial site).
• You have another serious illness or condition that, in the doctor's opinion, could make it unsafe for you to participate or could interfere with the trial.
• You have an active significant infection (such as a bacterial, fungal, or viral infection) that could affect how the trial drugs work or how your safety is monitored — note that patients who are HIV-positive may still be eligible if certain specific conditions are met (confirm with trial site).

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