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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.

Up to 100 participants will be enrolled in this multicenter study throughout the United States.

If the patient is found to be eligible to take part in this study based on the screening tests, they will randomly assigned (as in the flip of a coin) to 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other group. The patient will have an equal chance of being assigned to either group. Group A patients will receive trastuzumab and NeuVax. Group B will receive trastuzumab and sargramostim.

The patient will receive trastuzumab for a total of 12 months. This will be part of standard of care treatment. The patient will receive trastuzumab along with standard of care chemotherapy and then receive trastuzumab alone (this is called “maintenance therapy”). When the maintenance trastuzumab therapy begins, the patient will begin receiving NeuVax or sargramostim by injection into their skin along with trastuzumab. In the first part of the study, the patient will receive a NeuVax or sargramostim injection every 3 weeks for 6 doses. After that, starting 12 months after the first maintenance trastuzumab dose, the patient will receive NeuVax or sargramostim injections every 6 months for 2 years, for a total of 4 more doses.

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The map above depicts the locations where the clinical trial is taking place across the United States.

For more detailed criteria, eligibility, and trial specifics at ClinicalTrials.gov, please click here (Upcoming).

ClinicalTrials.gov Identifier: Upcoming

gov Link: Upcoming