ON THIS PAGE: You will learn more about clinical trials, which are the main way that new medical approaches are tested to see how well they work. Use the menu to see other pages.
What are clinical trials?
Doctors and scientists are always looking for better ways to care for patients with breast cancer. To make scientific advances, doctors design research studies involving volunteers, called clinical trials. In fact, every drug that is now approved by the U.S. Food and Drug Administration (FDA) was tested in clinical trials.
Many clinical trials focus on new treatments. Researchers want to learn if a new treatment is safe, effective, and possibly better than the treatment doctors use now. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Patients who participate in clinical trials can be some of the first to get a treatment before it is available to the public. However, there are some risks with a clinical trial, including possible side effects and that the new treatment may not work. People are encouraged to talk with their health care team about the pros and cons of joining a specific study.
Some clinical trials study new ways to relieve symptoms and side effects during treatment. Others study ways to manage the late effects that may happen a long time after treatment. Talk with your doctor about clinical trials for symptoms and side effects. There are also clinical trials studying ways to prevent cancer.
Deciding to join a clinical trial
Patients decide to participate in clinical trials for many reasons. For some patients, a clinical trial is the best treatment option available. Because standard treatments are not perfect, patients are often willing to face the added uncertainty of a clinical trial in the hope of a better result. Other patients volunteer for clinical trials because they know that these studies are a way to contribute to the progress in treating early-stage and locally advanced breast cancer. Even if they do not benefit directly from the clinical trial, their participation may benefit future patients with breast cancer. For example, the benefits of using dose-dense chemotherapy, which is giving the drugs more frequently than the traditional 3-week intervals, and adding trastuzumab for early-stage breast cancer were tested and confirmed in clinical trials.
Insurance coverage of clinical trials costs differs by location and by study. In some programs, some of the patient’s expenses from participating in the clinical trial are reimbursed. In others, they are not. It is important to talk with the research team and your insurance company first to learn if and how your treatment in a clinical trial will be covered. Learn more about health insurance coverage of clinical trials.
Sometimes people have concerns that, in a clinical trial, they may receive no treatment by being given a placebo or a “sugar pill.” Placebos are usually combined with standard treatment in most cancer clinical trials. When a placebo is used in a study, it is done with the full knowledge of the participants. Find out more about placebos in cancer clinical trials.
Patient safety and informed consent
To join a clinical trial, patients must participate in a process known as informed consent. During informed consent, the doctor should:
Describe all of the patient's options, so that the person understands the standard treatment, and how the new treatment differs from the standard treatment.
List all of the risks of the new treatment, which may or may not be different from the risks of standard treatment.
Explain what will be required of each patient to participate in the clinical trial, including the number of doctor visits, tests, and the schedule of treatment.
Clinical trials also have certain rules called “eligibility criteria” that help structure the research and keep patients safe. You and the research team will carefully review these criteria together.
Patients who participate in a clinical trial may stop participating at any time for any personal or medical reason, including if the new treatment is not working or if there are serious side effects. Clinical trials are also closely monitored by experts who watch for any problems with each study. It is important that patients participating in a clinical trial talk with their doctor and researchers about who will be providing their treatment and care during the clinical trial, after the clinical trial ends, and/or if the patient chooses to leave the clinical trial before it ends.
Finding a clinical trial
Research through clinical trials is ongoing for all types of cancer. For specific topics being studied for early-stage and locally advanced breast cancer, learn more in the Latest Research section. Talking with your doctor is a good way to learn more about research opportunities in your area.
Cancer.Net offers a lot of information about cancer clinical trials in other areas of the website, including a complete section on clinical trials and places to search for clinical trials for a specific type of cancer.
In addition, this website offers free access to a video-based educational program about cancer clinical trials, located outside of this guide.
The next section in this guide is Latest Research. It explains areas of scientific research currently going on for this type of cancer. You may use the menu to choose a different section to read in this guide.