A clinical trial is a research program conducted 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 scientific and technological advances to patient care.
During a breast cancer clinical trial, researchers, usually doctors, use the best available treatment as a standard to evaluate new treatments. These treatments may be a new drug, surgery, or an alternative medicine.
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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 humans, 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 the treatments currently available?
What are the side effects of the treatment?
Does the treatment have any possible risks?
How well does the treatment work?
What is the maximum tolerable dose of the drug?
What Are the Different Types of Breast Cancer Clinical Trials?
All clinical trials are conducted 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 phases III and IV.
Phase I clinical trials study the safety and toxicity of the new breast cancer treatment. It is determined what doses are safe to give and by what route -- by mouth, 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 occur if the treatment is found to be safe in the phase I trial. Phase II studies look at whether the treatment is effective, in persons 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 treatment is superior. These trials may include hundreds of people across the country. If a treatment does well in phase III studies, it may receive an FDA approval for use.
Phase IV clinical trials occur after the drug is approved by the FDA. These studies look at ways to use the new treatment more effectively. For example, in phase IV trials, researchers may test a drug in combination with other drugs. In other phase IV trials, they may study a new dose, or study the drug's effectiveness to treat a particular disease with a select group of patients. Several hundred to several thousand people may participate. These trials are less common than phase I, II, or III trials.