The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called ivonescimab when combined with standard chemotherapy (carboplatin and docetaxel) before surgery for the treatment of early stage, triple-negative breast cancer (TNBC). Researchers aim to determine whether the combination of these drugs will help the body’s immune system to fight cancer, increase the length of time that patients live with cancer, and keep the cancer from worsening. Participants will receive ivonescimab in combination with standard chemotherapy intravenously (through the veins) for 6 cycles before their planned surgery. During this time, the study will keep track of how patients are responding to treatment through quality-of-life questionnaires, as well as blood, stool, and tumor samples. Ivonescimab is a special type of monoclonal antibody (protein) that works by blocking 2 specific proteins called PD-1 and VEGF-A. Blocking these proteins may activate the immune system more efficiently than the standard-of-care PD-1 inhibitor to help fight cancer cells. The U.S. Food and Drug Administration (FDA) has approved the chemotherapy drugs, carboplatin and docetaxel, as they are being used in this study.
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What is the full name of this clinical trial?
IIT2024-09-YUAN-NeoIVO: Phase II Trial of Ivonescimab in combination with carboplatin + docetaxel in Patients with Early Stage Triple Negative Breast Cancer