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:

• People who are able to understand the study information and are willing to sign a consent form agreeing to take part
• People who are 18 years of age or older at the time of signing the consent form, of any gender
• People with breast cancer that cannot be removed by surgery and has either come back locally or spread to other parts of the body, and whose tumour has been previously tested and shown a specific low level of a protein called HER2 (recorded as IHC 1+, or IHC 2+ with a negative ISH test), and has never tested as high HER2 (IHC 3+, or IHC 2+ with a positive ISH test)
• People who have already received at least 1 to 2 courses of chemotherapy for their breast cancer after it returned or spread
• People who are willing to provide stored tumour tissue samples so a central laboratory can test the HER2 status
• People whose cancer has been shown on scans to have continued growing or spreading during or after their most recent treatment
• People who have at least one measurable area of cancer outside the brain, as assessed by standard imaging criteria (called RECIST 1.1)
• People whose life expectancy is estimated to be at least 3 months
• People who have a good general level of physical function, scored 0 or 1 on a standard scale (called the ECOG scale), within the 14 days before starting treatment
• People of childbearing potential, or men whose partners could become pregnant, who agree to use highly effective contraception from the time of signing the consent form
• People whose recent blood test results and heart function tests meet the required levels set by the trial (blood tests within 14 days, heart tests within 28 days before starting treatment)
• People who have waited long enough after their previous treatments for those treatments to have sufficiently cleared from their system before starting this trial (confirm with trial site)

Who may not be able to join:

• People who have brain metastases (cancer spread to the brain) that have not been treated or are not currently stable, or who have cancer spread to the spinal cord, or cancer involving the lining of the brain or spinal cord
• People whose only measurable areas of cancer are on the skin
• People who have had another type of primary cancer (a different cancer, not related to their breast cancer) within the 5 years before starting treatment
• People for whom the treating doctor determines that the comparison treatment used in this trial is not appropriate (confirm with trial site)
• People who have previously been treated with a type of drug called an antibody-drug conjugate that contains a topoisomerase I inhibitor
• People who have a significant build-up of fluid in body cavities (such as the chest or abdomen) that cannot be managed by drainage or other means
• People who have had, or currently have, a lung condition called interstitial pneumonia or interstitial lung disease that has required treatment with steroid (hormone) medication
• People who have difficulty swallowing, ongoing severe diarrhoea, a bowel blockage, or any other condition that would prevent them from taking oral medication or absorbing it properly
• People who have had, or currently have, an autoimmune disease (a condition where the immune system attacks the body's own tissues)
• People who have other serious medical conditions that are not well controlled
• People whose side effects from previous cancer treatments have not recovered to a mild level (grade 1 or lower on a standard scale) before starting the trial
• People with a history of immune system deficiency
• People who have previously had a life-threatening allergic reaction, or who have a known severe allergy (grade 3 or higher) to any ingredient in the trial medications
• People who have other conditions — including mental health conditions, or issues with alcohol or drug use — that the trial doctors believe could affect their safety or their ability to follow the treatment plan

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