When it comes to cancer, clinical trials are one of the biggest reasons we’ve seen gains in breast cancer survival over the past 40 years. And improved survival hasn’t been the only benefit.
Quality of life for people living with cancer has also improved as trials have helped identify more targeted treatments that can help limit many of the side effects of cancer therapies.
Most of us have heard the term “clinical trials” but haven’t given it much thought. Like a lot of important things that fly under the radar, clinical trials have had a huge impact on society.
At their most basic, clinical trial studies done in people test the safety and effectiveness of ways to prevent, detect or treat disease. Participants may benefit from clinical trials themselves, or their participation may benefit others in the future. They are the first to receive new treatments under investigation and, in cancer clinical trials, are guaranteed to receive the best standard care possible. And, clinical trials offer a way for women with breast cancer to play an active role in their own health care and help others by adding to medical research.
Most clinical research progresses through an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information, yet protects patients. Most clinical trials are classified into one of four phases, though there can be some overlap between types depending on the study.
Phase 1 (phase I): These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often and what dose is safe
Phase 2 (phase II):A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works against a certain disease
Phase 3 (phase III): These studies test a new drug, a new combination of drugs or a new surgical procedure in comparison to the current standard of care. A participant will usually be assigned to the standard group or the new group at random (called randomization).
Phase 4 (phase IV): Trials study the long-term side effects of the treatments or procedures or answer new questions about the treatment or procedure. They are done after a new breast cancer treatment or procedure is approved by the U.S. Food and Drug Administration.
There are many sources you can use for finding clinical trials. Each is a little different and some allow searching for trials based on factors like age, gender, breast cancer history, treatment history and geographic area as well as study-type preferences. For example, BreastCancerTrials.org in collaboration with Susan G. Komen®, offers a custom matching service that can help you find a clinical trial that fits your health needs. Though these sites can be helpful search tools, the best approach is to ask your doctor or local medical center for help finding an appropriate clinical trial.