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What Is a Clinical Trial?

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 physicians, use the best available treatment as a standard to evaluate new treatments. These treatments may be a new drug, surgery or an alternative medicine.

First, researchers study new treatment options in the laboratory in test tubes and animals. If those results are promising, new 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, there are possible risks as well as benefits. Clinical trials help physicians 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 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 of the new treatment.

Phase II clinical trials occur if the treatment is found to be safe in the phase 1 trial. Phase II studies look at whether the treatment is effective.

Phase III clinical trials compare the new treatment with the standard treatment to determine if it's any better.

If a treatment does well in phase II studies, it is often approved for use by the U.S. Food and Drug Administration (FDA).

Phase IV clinical trials occur after the drug is approved 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. Or they may study a new dose. Or they may study the drug's effectiveness to treat a particular disease or a select group of patients.