Phase 1 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 are willing to take part and have signed a consent form agreeing to join the study
• You are an adult aged 18 to 75 years old
• You have been diagnosed with HER2-positive advanced breast cancer, confirmed by a lab test on a tissue sample (HER2-positive means the cancer cells show a high level of a specific protein or gene that drives cancer growth)
• Your breast cancer has come back (recurred) or spread to other parts of the body (metastatic), and if it has only come back in a local area, a doctor has confirmed it cannot be fully removed by surgery
• You have at least one area of cancer that can be measured on a scan, or you have bone metastases only (including certain types of bone lesions)
• Your general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (confirm with trial site)
• Your blood counts, liver function, kidney function, and heart function all meet certain minimum levels based on recent blood tests (confirm with trial site for specific numbers)

Who may not be able to join:

• You have already received any cancer treatment (such as chemotherapy, immunotherapy, or targeted therapy) for your recurrent or metastatic breast cancer
• You have previously used certain targeted cancer drugs called tyrosine kinase inhibitors (TKIs) or certain antibody treatments aimed at HER2 at any point during your breast cancer treatment, with the exception of one drug called trastuzumab used after surgery
• Less than 12 months passed between finishing your earlier cancer treatment (after surgery) and your cancer coming back or spreading — not counting hormone therapy
• You have active cancer that has spread to the brain and is causing symptoms, or has spread to the lining around the brain, confirmed by a scan or spinal fluid test
• You have severe nerve damage in your hands or feet (grade 3 or higher, confirmed with trial site)
• A doctor has decided you are not suitable for chemotherapy
• You have taken hormone therapy drugs within the 7 days before joining the trial
• You have had another type of cancer in the past 5 years, except for certain types that have been fully cured (such as early-stage cervical cancer, or certain skin cancers)
• You had a major operation or serious injury within 4 weeks before joining the trial, or are expected to need major surgery soon
• You have serious heart problems, including a history of heart failure, dangerous irregular heartbeat, significant heart valve disease, a past heart attack shown on an ECG, or poorly controlled high blood pressure (confirm with trial site for specific details)
• You have difficulty swallowing, ongoing diarrhea, a bowel blockage, or any other condition that would prevent you from taking or absorbing the trial medication properly
• You have a known allergy to any of the ingredients in the trial drugs
• You have a weakened immune system, HIV infection, another immune deficiency condition, or have had an organ transplant
• You have a build-up of fluid in body cavities (such as around the lungs or in the abdomen) that cannot be controlled by draining or other methods
• You are pregnant, breastfeeding, or able to have children but unwilling to use effective contraception during the trial and for 3 months after the last dose
• You have another serious illness or condition that could interfere with the treatment, such as active hepatitis B or a lung infection requiring treatment

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