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Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2-expressing breast cancer patients to prevent recurrence

This study includes patients that have been treated for node-positive (NP) or high-risk node-negative (NN) breast cancer where they are at risk for recurrence (breast cancer coming back); and also because tumor cells show a specific protein called HER2/neu on their cell surfaces. “Node-positive” means that breast cancer has been found in the lymph nodes. “High-risk node-negative” for the purposes of this trial means that breast cancer has not been found in the lymph nodes but that the tumor is not sensitive to hormones which means that a patient may be at an increased risk for recurrence.

There will be approximately 300 people volunteering for this study from approximately 15-20 hospitals across the United States.

The purposes of this study are to (1) test the HER2/neu peptide (piece of the protein) E75 as a vaccine in combination with Herceptinâ (trastuzumab) to determine if it can prevent breast cancer recurrence; (2) to look at the immune system’s response to the vaccine in combination with Herceptin; and (3) to collect information on the safety of using the vaccine in combination with Herceptin.

HER2/neu is a protein that is found on breast cancer cells in very large amounts about 20 – 30% of the time and in moderate amounts about 60 – 70% of the time. This protein is recognized by the immune system as being dangerous. We have studied three different HER2/neu peptides as vaccines in breast cancer patients and shown in laboratory studies that all three can stimulate the immune system to recognize and kill cancer cells that have HER2/neu protein on their cell surfaces.

Herceptin (trastuzumab) is a man-made antibody (a protein that normally protects the body from foreign invaders, such as bacteria or viruses) that has been shown to increase the survival of some breast cancer patients when given with standard chemotherapy. It is believed to work by slowing the growth of tumors. The Food and Drug Administration (FDA) has approved the drug for the treatment of women with a type of breast cancer with a higher than normal number of receptors on the surface of their breast cancer cells called HER2/neu positive breast cancer. Although Herceptin has not been approved for the type of breast cancer in this trial, some research has shown it may be of value in treatment.

E75 is a HER2/neu peptide (a piece of a protein). The peptide is combined with another product called an “adjuvant” that is meant to improve the response of the immune system. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a FDA-approved medication. In this study, we use GM-CSF as an immunoadjuvant in an investigational method. An immunoadjuvant means that the medication GM-CSF is a substance added to the vaccine to improve the immune response.

During this study we will try to stimulate the patient’s own immune system to produce an immune response against HER2/neu. We want to see if this investigational drug, E75, will create or boost (increase) immunity against the patient’s tumor. This study is designed to find out its safety and effectiveness in the treatment of breast cancer.

Initially, blood tests will be performed to determine the patient’s HLA-type (a set of unique proteins expressed on all of the cells in your body). The HLA type must be HLA-A2 positive (A2+) or HLA-A3 positive (A3+) to be eligible for the study. If it is HLA-A2 negative (A2‾) and HLA-A3 negative (A3‾), the patient does not qualify for this study and will not receive the vaccine.

If the patient’s type is A2+ and/or A3+, they will be screened to see if they meet the other qualifications for the study. If the patient does qualify and chooses to participate in the trial, they will be randomized (flip of a coin) to determine if they will receive the E75 peptide and GM-CSF or GM-CSF alone. The patient will not know which one they are receiving. Everyone will receive Herceptin. There are approximately 40 outpatient visits to the clinic over 3 years that are required. The ultimate purpose of the study is to determine if the combination of Herceptin and the E75/GM-CSF vaccine will decrease the risk of breast cancer recurrence.


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, please click here. Identifier NCT01570036