Combination Immunotherapy for the Treatment of High-Risk HER2-Positive Breast Cancer
Technical Report,15 Sep 2018,14 Sep 2019
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 NeuVaxtrademark 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 past 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, 242 HLA eligible patients have signed screening consents. Of those 186 77 percent qualified for the study and 54 23 percent were considered screen failures based on HLA type. Among the qualified patients, 100 have been randomized to treatment, thus reaching target enrollment, and 86 who are HLA eligible did not proceed. Primary vaccination series have been completed for all randomized patients and booster inoculations are ongoing in 23 subjects as of October 2019. 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.
- Medicine and Medical Research