Breast Cancer Vaccine Clinical Trial

National Clinical Trial No. 01570036

Providence Regional Cancer Partnership is now enrolling patients for a new breast cancer vaccine clinical trial.  This national clinical research study will determine the effectiveness of a vaccine to prevent the recurrence of breast cancer.  The Cancer Partnership is one of only 13 locations in the United States offering the trial and the only site in Washington.
 
Why Is It Important For Me To Participate?
Breast cancer is the most common malignancy and second most common cause of cancer-related death among women in the United States. Despite advances in the diagnosis and treatment of breast cancer, one-third of the women who develop the disease will die of the disease, accounting for approximately 40,000 deaths per year. While good primary therapies such as surgery, radiation and chemotherapy are available to treat early stage breast cancer, there is a substantial failure rate to these therapies in more advanced disease.
 
Another way to attack cancer is to use therapies meant to stimulate a patient’s immune system to recognize and destroy tumor cells. These new therapies are known as immunotherapies. The ultimate goal of cancer immunotherapy research is to design safe and efficient therapies that can be used as preventive strategies for patients at risk for breast cancer recurrence. Because these immunotherapies are still in development, you may not benefit directly from being in this or other clinical trials: however, by participating in this trial, you may find satisfaction in taking part in research that will benefit the health of future generations.
 
What Is The Purpose Of This Research?
The specific purpose of this research is to test the development of an anti-cancer vaccine (NeuVax) in order to find out whether or not this vaccine will reduce the chance of cancer recurrence in women who have already been treated for breast cancer. The trial is also aiming to see if Herceptin®, a drug which is already approved for some types of breast cancer, can also be effective in combination with the vaccine against the type of breast cancer that you have.
 
The vaccine is made from a cancer protein called HER2/neu, which you may know was part of your tumor, and GM-CSF, an FDA-approved drug that stimulates bone marrow to make new white blood cells. Earlier studies in breast and ovarian cancer patients showed that the body makes T-cells (killer white blood cells) in response to the vaccine. The vaccine has been found to be safe in Phase I trials (the earliest human testing meant to show safety).
 
Furthermore, in additional trials, stimulation of the immune system by this vaccine appears to reduce the rate of breast cancer recurrence in patients with either a node-positive or a high-risk node-negative breast cancer. Therefore, in this study, we are testing the combination of Herceptin and the vaccine to see if the two will be even better together in preventing recurrences.
 
Who Is Eligible To Participate?
You are eligible if you have had a diagnosis of invasive breast cancer; if you are at risk for your breast cancer coming back; and if your tumor cells show a specific amount of protein called HER2/neu on their cell surfaces. You must also pass a screening process to see if you are eligible to receive the vaccine and if it is safe for you to do so.
 
What Is The Screening Process?
This evaluation (screening) will include a review of your general health and any medical problems. As well, the screening will review laboratory testing to check the health of your internal organs, and perform HLA typing (a sort of blood type for your cells). If you are HLA-A2 or A3 positive (approximately 70% of Americans), you will be eligible to receive either Herceptin® + NeuVax (E75 +GM-CSF) or Herceptin® + GM-CSF alone. You will not be told which you are receiving.
 
How Long Is The Research And How Often Will I Need To Come In for My Research Study Treatments?
Total participation time in the trial is 36 months, and there are approximately 40 visits over this 3 year period. Many of these visits will only last 15 minutes, but some will last for 1 ½ hrs.
 
How Are The Herceptin® And Vaccine Injections Given?
The Herceptin® is given through a vein in your arm or through your chemotherapy port, if you still have this. The vaccine injections will be administered into the skin on your leg in 2-4 injections.
 
Can You Tell Me More About The Blood Draws?
Prior to the first Herceptin® IV infusion, and prior to some of the vaccine injections, you will have approximately 10 teaspoons of blood drawn each time to perform tests to see if your immune cells are responding to the study treatments. Blood is drawn approximately 12 times during the trial.
 
Where Can I Find Out More About This Study?
A description of this clinical trial is available on http://www.ClinicalTrials.gov under National Clinical Trial No. 01570036, as required by U.S. Law.  
 
How Do I Become Involved?
To determine eligibility, please call the Providence Regional Cancer Partnership at 425-297-5500.

Learn more about Providence Regional Cancer Partnership