Phase II Trial of Combination Immunotherapy with nelipepimut-S + GM-CSF (NeuVax) and Trastuzumab in high-risk HER2+ Breast Cancer Patients (2014-0443)

The goal of this trial is to compare if and for how long trastuzumab combined with either NeuVax (nelipepimut-S given with GM-CSF [sargramostim]) or sargramostim can help control the disease in patients with HER2 positive breast cancer. NeuVax is not FDA approved or commercially available. It is currently being used for research purposes only. Sargramostim is FDA approved and commercially available to help raise patients’ white blood cell counts after chemotherapy. Giving NeuVax or sargramostim to patients with HER2-positive breast cancer is investigational. Trastuzumab is FDA approved and commercially available to treat HER2-positive breast cancer.