Combination Immunotherapy for the Treatment of High-Risk HER2-Positive Breast Cancer
Technical Report,15 Sep 2016,14 Sep 2017
The University of Texas MD Anderson Cancer Center Houston United States
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The goal of the proposed research is to complete a clinical trial that evaluates the ability of the combination of trastuzumab and the HER2-derived vaccine NeuVaxTM nelipepimut-S administered with the immunoadjuvant, GM-CSF in the adjuvant setting to prevent metastatic disease in high-risk HER2-positive breast cancer patients. Completion of the trial will allow us to test our hypothesis that combination therapy with trastuzumab plus vaccination is a therapeutic modality that has minimal toxicity and will prevent disease recurrence. During this third year of funding, we have continued to accrue patients to the clinical trial Specific Aim 1. To date, across the 22 sites participating in this trial, 205 HLA eligible patients have signed screening consents. Of those 157 77 qualified for the study and 48 23 were considered screen failures based on HLA type. Among the qualified patients, 82 have been randomized to treatment, 13 are HLA eligible and pending randomization, and 62 who are HLA eligible did not proceed reported values as of 6 Oct 2017. Pre-vaccine series delayed type hypersensitive response evaluations have been completed for all randomized patients. Blood samples for immunologic monitoring are being collected at the specified time points, processed, and stored for the planned analyses described in specific aims 2 and 3.
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