This study is looking at a type of cancer called breast cancer that has spread to other parts of the body or cannot be removed by surgery. The cancer being studied is a specific type that is hormone receptor-positive and HER2 IHC 0, which means the cancer cells have receptors for hormones but do not have a protein called HER2 on their surface, or have very low levels of it. The cancer must also be resistant to or not suitable for hormone-based treatments, which are medications that work by blocking hormones that help cancer grow. The treatment being tested in this study is called Datopotamab deruxtecan, which is given through a vein as an infusion. This medication is a type of drug that combines an antibody with a cancer-fighting substance to target cancer cells more directly.
The purpose of this study is to see how well Datopotamab deruxtecan works in stopping the cancer from getting worse, which is measured by looking at how long patients live without their cancer progressing. The study will also look at how safe the medication is by checking for side effects such as mouth sores, eye problems, and other serious reactions. Patients in this study will receive the study medication and will be monitored regularly to see how their cancer responds to treatment and to check for any side effects. The study will also measure how many patients have their cancer shrink or stay the same size, how long any positive response to treatment lasts, and how long patients survive after starting the treatment.
During the study, doctors will take images and samples to track how the cancer is responding to the medication. The study is designed for patients whose cancer has a specific pattern of hormone receptors and HER2 levels, and who are not suitable candidates for another similar medication. Patients will need to have a certain level of general health and organ function to participate, and their cancer must be measurable or visible on scans. The study will continue for several years to collect information about how well the treatment works over time.



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