A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety ofHER2/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)
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy.
Primary Objective: To assess the efficacy of GLSI-100 compared to placebo in HLA-A*02 positive and HER2/neu positive breast cancer subjects who have a high risk of disease recurrence (stage I, II, or III at presentation with residual disease at surgery or stage III at presentation with pathologic complete response [pCR] at surgery) and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based standard of care therapy.
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
Patient can begin study therapy within 90 days of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but,study therapy can be administered concurrently with endocrine therapy.
No clinical evidence of residual or persistent breast cancer per treating physician assessment
Adequate organ function
Negative pregnancy test or evidence of post-menopausal status
If of childbearing potential, willing to use a form of highly effective contraception
Stage IV cancer or metastatic breast cancer at any time
Inflammatory breast cancer
Receiving other investigational agents
Requiring 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
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 within 6 months of the anticipated start of treatment are eligible for this trial.
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