Research Clinical Trials

The idea of being the first to use a new drug or new treatment scares me.

A new drug or treatment approach undergoes very carefully controlled testing in several phases long before it would ever be offered to you. The large clinical trials in which most breast cancer patients can participate are called Phase III trials.

Before Phase III trials, the new treatment has already been tested successfully in many patients in Phase I and Phase II trials. Phase I trials establish how a drug should be administered, how often, and in what dosage. Phase II trials provide preliminary information on how well the drug works, and more information on its risks and benefits.

A new treatment is not even considered for a large-scale Phase III trial unless it looks like an improvement in treatment and seems to be as safe as the standard treatment. And most drugs take years of development and laboratory testing before the three phases of testing in people can begin.

Large clinical trials are done according to very strict guidelines, called "protocols". Protocols describe the goals of the study, who can be in the study, what drugs and tests participants will take, how many patients are to be enrolled, the information that will be collected, and the information people must be given when they are deciding to participate. Before the trial begins, the protocol is reviewed by groups of patient advocates, health care providers, scientists, and statisticians. These reviews are designed to ensure that the study makes sense, that patients' safety is safeguarded, and that upon completion of the study, the results will be valid.

First, patients are assigned at random to either the standard therapy group or to the new treatment group. This is called a randomized trial. If you are assigned to the standard group, you receive what experts view as the best treatment currently available. If you are assigned to the new treatment group, you receive a treatment that some experts think may have significant advantages over the standard.

There's got to be some risks involved in participating in a clinical trial.

Of course. There are well-known risks associated with many standard cancer therapies, which your doctor will explain to you before you embark on a particular course of treatment. And since there has been less experience with a new treatment, not all the risks can be anticipated ahead of time. But the people who design the clinical trial believe that the new treatment will be as good as or better than the current standard care, and that the potential benefits will outweigh the risks. By participating in a trial, you have an opportunity to be one of the first to benefit if the treatment is successful.