Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Ireland, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients who have previously undergone surgery [7][8]. Clinical Trial Details - FLAMINGO-01 (NCT05232916) is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery [5]. - The trial is led by Baylor College of Medicine and includes clinical sites in the US and Europe, with plans to open up to 150 sites globally [5]. - Approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 or placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Expansion to Ireland - The application to European regulators for including Ireland in the FLAMINGO-01 trial has been formally approved, adding to existing sites in Spain, France, Germany, Italy, Poland, Romania, and the US [2]. - Dr. Janice Walshe will serve as the national principal investigator in Ireland, collaborating with Cancer Trials Ireland to provide access to novel agents for Irish women affected by breast cancer [4]. Breast Cancer Statistics - In 2022, Ireland reported 3,723 new cases of breast cancer, making it the most common cancer diagnosed in women, accounting for approximately 30% of all cancers in women [3]. - Breast cancer is the second leading cause of cancer-related deaths among women in Ireland, with 883 deaths recorded in 2022 [3].