A clinical trial is a research program done with patients to evaluate a new medical treatment, drug, or device. The purpose of a breast cancer clinical trial is to find new and improved methods of treating the disease. Clinical trials make it possible to apply the latest advances to patient care.
During a breast cancer clinical trial, researchers, usually doctors, use the best available treatment as a standard by which to assess new treatments. These treatments may be a new drug, surgery, or an alternative medicine.
Breast cancer is a complex disease that’s different for every woman. Before you start a treatment, your doctor will want to know the size of the tumor and how far it has spread in your body, called the stage of the cancer. There are five basic stages, 0 through IV, and a number of sub-stages.
Staging is a way for doctors to describe your condition. It doesn't tell the whole story, though. Your doctor will think about many things before she recommends treatments for you, including:
First, researchers study new treatment options in the laboratory, in test tubes, and in laboratory animals. If results are promising, these treatments are further evaluated in a small group of people and, finally, in a larger clinical trial.
When a new medical treatment is studied for the first time in people, no one knows exactly how it will work. With any new treatment for breast cancer, there are possible risks as well as benefits. Clinical trials help doctors discover the answers to these questions:
Is the treatment safe and effective?
Is the treatment potentially better than ones already available?
What are the side effects of the treatment?
Does the treatment have any risks?
How well does the treatment work?
What is the maximum tolerable dose of the drug?
What Are the Different Types?
All clinical trials are done in phases, each designed to find out specific information. Each new phase of a clinical trial builds on information from previous stages.
Participants may be eligible for clinical trials in different phases, depending on their health. Most clinical trial participants take part in phase III.
Phase I clinical trials study the safety of the new breast cancer treatment. It is determined what doses are safe to give and by what route -- by mouth, or injection into a vein or muscle -- and how often it should be given. Phase I clinical trials usually enroll a very small number of people.
Phase II clinical trials happen if the treatment is found to be safe in the phase I trial. Phase II studies look at whether the treatment is effective, in people with advanced disease, and in certain cancers. Phase II clinical trials generally involve fewer than 100 people.
Phase III clinical trials compare the new treatment with the standard treatment to determine which one is superior. These trials may include hundreds of people across the country. If a treatment does well in phase III studies, it may receive FDA approval for use.