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Clinical Trials

Clinical trials are critical to the development of new cancer treatments. Without clinical trials, there would be no way to determine if new treatments are safe and effective, what risks or side effects they have, and whether they are equivalent to or superior than treatments already in use.

Because new trials are getting underway all the time, breast surgeons, radiologists, and oncologists are not always aware of all the trials open to their patients. Cancer patients frequently must do their own research to find the clinical trials that may be right for them.

Clinical trials are divided into four phases

  • Phase I: Researchers test a new drug or treatment to determine its safety, assess what dosage is best, and identify side effects. These studies usually only enroll a small number of people.
  • Phase II: Researchers look at whether the drug or treatment is effective. They also assess safety and side effects. These trials generally involve fewer than 100 people.
  • Phase III: Researchers compare the new drug or treatment with the standard treatment to determine which is more effective and which has more side effects. These trials often include hundreds or thousands of people. New treatments need to do well in Phase III studies to receive approval from the U.S. Food and Drug Administration (FDA).
  • Phase IV: These trials are conducted after a drug has received FDA approval to assess any side effects associated with long-term use.

Before you begin searching for a clinical trial, you will need to have some information about your tumor, such as it’s size and stage. You will also need to know if it is hormone sensitive or HER2-positive. If you are being treated for metastatic breast cancer, you will need to know where your cancer has spread and what other treatments you have had, if any.

If you find a trial that interests you, contact the study coordinator. The coordinator will work with you to determine if you are eligible for the trial. You should also talk to your doctor about the study you are interested in and if your doctor does not think the trial is right for you, find out why. You can discuss your doctor's concerns with the study coordinator. If there is still no agreement, you may want to get a second opinion from another oncologist. You should also talk to the study coordinator about what the trial will cover and what may be required of your health insurance company.

How to Find a Clinical Trial

There is no one central database for all breast cancer studies and clinical trials. The following websites provide more information about what you can expect if you enter a clinical trial and how to find a trial you may qualify for:

In addition, many cancer centers have a section of their website that lists the clinical trials they currently have open.