CLINICAL TRIALS

In most research studies, some patients are placed in a “control group.” The people in the control group receive the standard treatment so that their results can be compared with those who receive the new treatment. Clinical trials take a long time to complete, as thousands of patients may participate. Until a trial is over, the true value of the new treatment is not known.

Most clinical trials are designed by the national cancer institute or by large multi-institutional “cooperative groups”. The trials all must be approved by your hospital or outpatient clinic’s IRB (institutional review board) which has high standards for safety and patient care.

Research studies for breast cancer are being conducted in many hospitals and cancer centers throughout the United States. In these clinical trials, doctors use the newest treatments to care for cancer patients. Each carefully planned study is designed to answer certain questions and to find out specific information about how well a new drug or treatment method works. All new treatments must go through three steps or “phases” of clinical trials.

Phase 1: Tests the best way to give a new treatment and what dose can be safely given. Data on toxicity is collected. Usually patients with all types of cancer can participate.

Phase 2: Finds out how well a treatment works on a specific type of cancer, such as breast cancer.

Phase 3: Compares two or more different treatments, usually the standard treatment is compared to a new treatment, side by side.

All clinical-trial participants must give informed consent to be part of the trial. Participation is wholly voluntary and a patient may leave the trial at any time she wishes.

If you are interested in participating in a clinical trial, talk with your doctor. He or she can give you information that will help you decide if a clinical trial is right for you. The National Cancer Institute has produced a pamphlet, “Taking Part in Clinical Trials: What Cancer Patients Need to know.” Call NCI’s Cancer Information Service at 1-800-4-CANCER for further information or contact their website at www.nci.nih.gov or http://cancer.gov/clinicaltrials.

Results of clinical trials are shared with the oncology profession regularly through numerous vehicles including national and regional medical meetings, peer-reviewed journals, educational books and publications, and mailings. Your doctor will have access to the latest research results in breast cancer care.

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