This study involves patients with endometrial cancer, which is cancer of the lining of the uterus, that has come back after previous treatment. The study is looking at patients whose cancer shows a protein called HER2 on the surface of the cancer cells. Patients in this study will receive either an investigational treatment called BNT323, which is given through a vein, or a chemotherapy medicine chosen by their doctor. The chemotherapy options include paclitaxel, which is a medicine that stops cancer cells from dividing, or doxorubicin hydrochloride, which is a medicine that damages the genetic material inside cancer cells to stop them from growing.
The purpose of the study is to compare how well BNT323 works against the doctor’s choice of chemotherapy in stopping the cancer from getting worse or spreading. The study will measure how long patients live without their cancer growing or spreading, and how long patients survive overall. The study will also look at how many patients have their tumors shrink or disappear, how long these responses last, and what side effects occur with each treatment. Patients will be assigned to one treatment or the other by chance, similar to flipping a coin, and both the patients and their doctors will know which treatment is being given.
During the study, patients will receive their assigned treatment for up to six months, and they will be monitored regularly with scans and tests to see how their cancer is responding and to check for any side effects. The study will track whether the cancer grows or spreads, and doctors will use specific measurement criteria to evaluate the size and extent of the tumors throughout the treatment period. The information gathered will help determine whether BNT323 is more effective than standard chemotherapy for treating this type of recurring uterine cancer.
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