This clinical trial is focused on studying treatments for breast cancer, specifically for patients with Triple-Negative Breast Cancer (TNBC) or hormone receptor-low/HER2-negative breast cancer. The study will evaluate the effectiveness of a new treatment combination involving Datopotamab Deruxtecan (Dato-DXd) and Durvalumab, both given before and after surgery. This will be compared to the current standard treatment, which includes Pembrolizumab and chemotherapy, also administered before and after surgery. The purpose of the study is to determine if the new treatment combination is more effective than the standard treatment.
Participants in the study will receive either the new treatment combination or the standard treatment. The new treatment involves the use of Dato-DXd, a medication designed to target and destroy cancer cells, and Durvalumab, which helps the immune system fight cancer. These medications will be given through an intravenous infusion, which means they are delivered directly into the bloodstream. The standard treatment includes Pembrolizumab, another medication that boosts the immune system, along with chemotherapy, which uses drugs to kill cancer cells. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.
The study will follow participants over a period of time to monitor their response to the treatments. This includes checking for the absence of cancer in the breast and lymph nodes after surgery, as well as tracking the time until any signs of cancer return or other health events occur. The goal is to see if the new treatment can improve outcomes for patients with these specific types of breast cancer. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.
Austria 
Belgium 
Bulgaria 
France 
Germany 
Hungary 
Italy 
Poland 
Spain