This study is looking at advanced breast cancer that expresses a protein called HER2. Breast cancer can have different levels of HER2 protein on the cancer cells, ranging from high levels (called HER2-positive) to low levels (called HER2-low or HER2-ultralow). The study will also look at whether the cancer has hormone receptors, which are proteins that can be found on some breast cancer cells. The treatment being tested is called Disitamab Vedotin, also known by its code name SGN-DV, which is given through a vein as an infusion. This medication is designed to target cancer cells that have HER2 on their surface.
The purpose of this study is to see how well Disitamab Vedotin works against advanced breast cancer in different groups of patients based on their HER2 and hormone receptor levels, particularly in patients who have already received other HER2-targeted treatments like trastuzumab deruxtecan. The study will look at several groups including patients with HER2-positive breast cancer, patients with hormone receptor-positive and HER2-low breast cancer, patients with hormone receptor-positive and HER2-ultralow breast cancer, and patients with hormone receptor-negative and HER2-low breast cancer, which is also called triple-negative breast cancer.
During the study, patients will receive Disitamab Vedotin and doctors will monitor how the cancer responds to the treatment by checking if tumors shrink or stop growing. The study will also track how long any positive responses last, how long patients live without their cancer getting worse, and overall survival. Blood samples will be taken to measure how the medication moves through the body and whether the immune system develops a response to the medication. Doctors will carefully watch for any side effects and will record any health problems that occur during treatment, including whether any changes need to be made to the treatment plan because of these side effects.



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