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Is a Breast Cancer Clinical Trial Right for You?
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 doctors, 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 for breast cancer, there are possible risks as well as benefits. Clinical trials help doctors 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 breast cancer treatment. Often it is determined what doses are safe to give and by what route -- by mouth, injection into a vein or muscle and how often it should be given. Phase I clinical trials usually enroll a very small number of people.
- Phase II clinical trials occur if the treatment is found to be safe in the phase I trial. Phase II studies look at whether the treatment is effective. Phase II clinical trials generally involve fewer than 100 people.
- Phase III clinical trials compare the new treatment with the standard treatment to determine if it's any better. These trials may include hundreds of people across the country. If a treatment does well in phase II studies, it is often approved for use by the 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. Several hundred to several thousand people may participate. These trials are less common than phase I, II, or III trials.
WebMD Medical Reference
Breast Cancer Guide
VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
October is National Breast Cancer Awareness Month, and a new study reveals why a high number of women with the disease still prefer to have the entire breast surgically removed instead of just the tumor. It's not always because doctors recommend it.
