Here is some general information about how "clinical trials," the term physicians use to describe research studies, are conducted. Research studies are essential to the goal of curing breast cancer, but they require many participants in order to learn what will help more women. We are providing this information with the hope that it will encourage you to consider a research study, and help doctors to treat women with breast cancer or those at increased risk more effectively.

Recent advances, particularly in detection, therapy, and side effect management have helped more women with breast cancer live longer. Yet despite these advances, over 177,000 women will be diagnosed with breast cancer this year and 44,000 women will die. Less than 50% of the women treated for breast cancer with surgery, radiation, and/or chemotherapy will ever have recurrences, but we don't feel that figure is low enough. There are still many questions:

• How do we truly prevent breast cancer?
• How do we find and treat breast cancer before it's big enough to see?
• Which therapies should be used for different kinds of breast cancer?
• What is the best way to use these therapies?
• How do we identify sub-groups of women who benefit from a particular therapy?
• How do we accurately and sensitively determine a woman's response to therapy?
• Why do some cancers metastasize (move to other sites) and others don't?

You can plan an important role in helping to answer these questions by considering a research study. Each study follows a plan called a "protocol." Most trials enroll patients at multiple locations. Each location must get approval to host a study from an "Institutional Review Board" (IRB) or "Committee for Human Research" (CHR) before they can offer it to you. This committee makes sure that you are not being asked to take unnecessary risks. A separate "Data Safety and Monitoring Committee" then tracks the study's progress to make sure it's done well.

Before you enroll in a research study, a person will describe the study to you in language that you can understand, including possible risks and benefits. This is called "informed consent." Please ask all the questions that will help you understand why your doctors are doing the study and what you will be expected to do. Keep asking until you feel comfortable about participating. Your questions might include:

• What exactly is the procedure or treatment and is it safe?
• How does it compare to the "standard" procedure?
• Who might benefit from this study?
• How much of my time will it take compared to "standard" procedures?
• How much will it cost?
• What are my other options?

When your questions have been answered to your satisfaction, you will be asked to sign a consent form confirming that you are willing to participate in that one specific study. If you do enroll in a clinical trial, you can change your mind at any time and decide not to participate.

We want you to make the best decision for your particular situation. That may or may not include participating in a clinical trial. If you are not interested, it won't affect the care that you receive from UCSF.