This study wants to learn if 6 months of HER2-targeted treatment works as well as 12 months of HER2-targeted treatment for people with early stage HER2-positive breast cancer who had no cancer found at surgery after chemotherapy and trastuzumab. This study also wants to learn how the 2 treatment lengths affect quality of life.
HER2-targeted drugs such as trastuzumab, with or without pertuzumab, are used to help lower the chance that breast cancer will come back. The usual treatment is about 12 months. This study is testing whether a shorter treatment time of about 6 months may work just as well for some people. If you join this study, you will be placed in 1 of 2 groups by chance, like flipping a coin. One group will get 12 months of HER2-targeted treatment. The other group will get about 6 months of treatment. The study doctor will talk with you about whether pertuzumab is part of your care. The drugs are given through a vein in your arm or as a shot in the thigh. The number of treatment rounds you get after survey will depend on how much treatment you had before surgery. During study visits, the study team and your doctor will check your health. You may have exams, blood tests, and other routine tests to see how you are doing and check for side effects. You will also complete short surveys about side effects during the study. After treatment ends, the study team will follow your health every 6 months for about 5 years, then once a year until 10 years after you joined the study. You will not be paid for being in this study. You and your insurance will need to pay for your routine medical care.
You may be able to join this study if you have early-stage HER2-positive breast cancer, and finished chemotherapy with trastuzumab before surgery. You must also have had no invasive cancer in the breast or lymph nodes at surgery. People with either hormone receptor positive or hormone receptor negative disease may be able to join the study if they meet certain criteria. Your doctor or a study team member will review these requirements with you. You can click on the NCT number link below to learn more about this study on ClinicalTrials.gov.
Protocol Number: 25-2075
More information available at ClinicalTrials.gov: NCT06876714
Principal Investigator