Clinical Trials for Breast Cancer

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Should you or shouldn't you? Weighing the pros and cons of joining a breast cancer clinical trial.

By Gina Shaw
WebMD Feature

Reviewed By Charlotte Grayson

Only about 3% of women with breast cancer take part in clinical trials, according to Y-ME, the national breast cancer organization.

This low level of clinical research participation may be stalling treatment progress. The fewer women who join clinical trials, the longer it takes to get data about whether a new treatment is an improvement over existing ones.

Should you join a breast cancer clinical trial? If you do, how can you choose the best one for you?

"Patients should be biased toward clinical trials," says Clifford Hudis, MD, Chief of the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center in New York. "If you [are seen at a medical] center and they have a trial for which you're appropriate, you should seriously consider it."

What are the advantages of participating in a clinical trial?

• You'll have access to the latest treatments before they're widely available. "Your list of available treatment options is finite, and clinical trials will sometimes represent options that don't exist outside the trial," says Hudis.
• You'll receive expert care and close monitoring. Although all women with breast cancer are monitored closely, clinical trial members are likely to receive an even higher level of scrutiny.
• You'll be contributing to the advancement of medical research that may benefit not only you, but many other women -- maybe even your own daughters and granddaughters.

Does that mean that there are no down sides to participating in clinical trials? Of course not. "Any time you're trying a new treatment or one with which we have less experience, there's always some potential for greater risk," says Eric Winer, MD, director of the Breast Program at Boston's Dana-Farber Cancer Institute.

Potential negatives include:

• The new treatment may not work as well as existing treatments.
• The new treatment may involve more difficult side effects than existing treatments.
• The trial may involve more work for you. Being in a clinical trial might mean additional appointments, extra blood draws or imaging studies, and more paperwork, for example.

You may think that if you're not being treated at a major, nationally known cancer center such as Sloan-Kettering or Dana-Farber, you won't have the opportunity to participate in clinical trials. Not true.

"Many smaller community hospitals and cancer centers have trials available to them, either on their own or as part of larger cooperative groups," says Winer.

Before signing up for a clinical trial, find out as much as possible about what's involved. Here are some important questions to ask, according to Clinicaltrials.gov -- a web site sponsored by the National Institutes of Health:

• What is the purpose of the study, and who will be in it?
• What kind of experimental treatment is involved, and has it been tested before?
• What are the possible risks, side effects, and benefits compared with my current treatment?
• How long will the trial last, and how will it affect my daily life?
• Will the trial mean any extra costs to me compared with standard treatment?
• Who will be in charge of my care?
• How will I know if the treatment is working? Will results of the trials be provided to me?

Some of your best sources for finding clinical trials:

• The National Institutes of Health. www.clinicaltrials.gov
  This NIH-sponsored web site provides regularly updated information about federally and privately supported clinical research with human volunteers. The database currently has some 256 breast cancer trials (listed under the heading "breast neoplasms").
• The National Cancer Institute. http://www.cancer.gov/clinicaltrials
  Call 1-800-4-CANCER, or visit the NCI's own web-based gateway to cancer-related clinical trials. This site also offers a step-by-step guide on choosing a cancer clinical trial.
• 
  Powered by Centerwatch, this service lists industry- and government-sponsored clinical trials. More than 500 breast-cancer-related trials are in the database currently.
• The Coalition of National Cancer Cooperative Groups. www.cancertrialshelp.org
  Run by a network of cancer clinical trials specialists, this site's Trialcheck search tool finds the trials best suited to you based on a series of nine questions.

Remember, the current "gold standard" treatments that you're benefiting from now wouldn't be available if other women hadn't joined clinical trials.

"I don't think we can say this enough. By participating in a trial, women with breast cancer are adding to knowledge that will help countless other women in the future," says Winer.

Published May 2005.

SOURCES: Eric Winer, MD, director, Breast Program, Dana-Farber Cancer Institute, Boston. Clifford Hudis, MD, chief, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, New York City. Y-ME, the National Breast Cancer Organization, Chicago. National Institutes of Health, Bethesda, Md.

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