A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01) - GLSI-21-01

Greenwich LifeSciences Inc.0 个研究点目标入组 477 人开始时间: 2023年10月18日最近更新: 2024年7月22日

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•Aged > 18 years, Negative pregnancy test or evidence of post-menopausal status, If of childbearing potential, willing to use a form of highly effective contraception, HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm, Histologically confirmed diagnosis of HER2/neu positive primary breast cancer, Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy, Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy OR Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy, The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but study therapy can be administered concurrently with endocrine therapy. Concurrent neratinib is prohibited., No clinical evidence of residual or persistent breast cancer, ECOG 0-2, Adequate organ function

•Stage IV cancer or metastatic breast cancer at any time, Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Subjects on effective antiretroviral therapy with an undetectable viral load for a minimum of 6 months of the anticipated start of treatment are eligible for this trial, Inflammatory breast cancer, Receiving other investigational agents, Receiving chemotherapy, Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy, History of immunodeficiency or active autoimmune disease, A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product, Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin, Active infection

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