ON THIS PAGE: You will learn more about clinical trials, which are the main way that new medical approaches are studied 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 people with breast cancer. To make scientific advances, doctors design research studies involving volunteers, called clinical trials. Every drug that is now approved by the U.S. Food and Drug Administration (FDA) was tested in clinical trials.
Clinical trials are used for all types and stages of breast cancer. Often, clinical trials are the best option to treat breast cancer. Many focus on new treatments to learn if a new treatment is safe, effective, and possibly better than the existing treatments. These types of studies evaluate new drugs, different combinations of treatments, new approaches to radiation therapy or surgery, and new methods of treatment.
People 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 the chance 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.
Deciding to join a clinical trial
People decide to participate in clinical trials for many reasons. For some, a clinical trial is the best treatment option available. Because no standard treatments are perfect, patients are often willing to face the added uncertainty of a clinical trial in the hope of a better result. Others 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 people 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 and the costs of clinical trials differ by location and by study. In some programs, some of the 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.” Breast cancer trials never use a placebo instead of standard treatment. Most often in a breast cancer treatment clinical trial, you will receive either the new treatment or the standard treatment. So even if you do not get the new drug or other new therapy, your breast cancer will be treated the same as if you were not in the trial. Sometimes, you may get the standard treatment plus a placebo rather than the standard treatment plus the new treatment being studied. Study participants will always be told when a placebo is used in a study. Find out more about placebos in cancer clinical trials.
Patient safety and informed consent
To join a clinical trial, people must participate in a process known as informed consent. During informed consent, the doctor should:
Describe all of the treatment 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 person to participate in the clinical trial, including the number of doctor visits, tests, and the schedule of treatment.
Describe the purposes of the clinical trial and what researchers are trying to learn.
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. You will need to meet all of the eligibility criteria in order to participate in a clinical trial. Learn more about eligibility criteria in clinical trials.
People who participate in a clinical trial may stop participating at any time for personal or medical reasons, 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 people 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 they choose 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 more 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, you can find a free video-based educational program about cancer clinical trials in another section of this website.
The next section in this guide is Latest Research. It explains areas of scientific research for breast cancer. Use the menu to choose a different section to read in this guide.