Phase 2 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 have been diagnosed with stage I–III breast cancer that tests positive for HER2 (a specific protein on cancer cells), confirmed by a tissue biopsy, with a tumour measuring at least 1 cm
• People whose doctor has determined that chemotherapy before surgery — using the drugs Paclitaxel, Trastuzumab, and Pertuzumab — is an appropriate treatment plan
• People who are generally well enough to carry out daily activities with little to no limitation (this is measured by a standard scale called ECOG, scores 0 or 1)
• People whose blood tests show that organs such as the liver, kidneys, and bone marrow are functioning within normal ranges as defined by the trial
• People whose heart pumping function is within normal range, as measured by a heart scan (either a MUGA scan or an echocardiogram) before the trial begins
• People who are able and willing to use effective contraception (hormonal, barrier methods, or abstinence) throughout the trial; women who become pregnant during the trial must inform their treating doctor immediately, and sexually active male participants must use a barrier method or abstinence during chemotherapy until surgery
• People who are able to understand the trial and are willing to sign a written consent form

Who may not be able to join:

• People with inflammatory breast cancer, disease that has spread too widely to be removed by surgery, or cancer that is suspected or confirmed to have spread to other parts of the body (metastatic disease)
• People who are currently taking part in another clinical trial using an experimental treatment for their breast cancer
• People with a history of serious allergic reactions to substances similar to the study vaccine components or to any of the chemotherapy drugs used in this trial (Paclitaxel, Trastuzumab, or Pertuzumab)
• People who are unwilling or unable to undergo a procedure called apheresis, which is used to collect cells from the blood to make the personalised vaccine used in this trial
• People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• Women who are pregnant or currently breastfeeding
• People with a known weakened immune system, whether from birth or due to a medical condition, including people who take medications that suppress the immune system for conditions such as autoimmune disease or following an organ transplant

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