These FAQs are only an introduction to clinical trials. For more information on finding clinical trials or understanding terminology related to clinical trials, please visit BreastCancerTrials.org’s FAQ section.
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and most effective way to find new methods of preventing, diagnosing and treating breast cancer. Cancer clinical trials are divided into four main categories: prevention, screening, treatment and quality of life.
No. Many breast cancer clinical trials are conducted at local hospitals. Some also take place at local cancer clinics and doctor's offices.
Ask your doctor about clinical trials for which you might qualify. You can find information about the importance of participating in clinical trials from the Clinical Trials section of our website. You can also contact the National Cancer Institute (NCI) Cancer Information Service at 800.422.6237, visit the NCI website for listings, or visit BreastCancerTrials.org, which provides easy to read descriptions of open breast cancer trials as well as tools to search for them.
Yes. Sometimes clinical trials give patients the chance to benefit from improved treatment methods before the new treatment becomes the standard of care for all breast cancer patients. However, there are usually several phases of clinical trials for each new treatment studied, and earlier trials may consist of smaller doses in order to determine efficacy and observe side effects. It is important to ask about clinical trials before you receive any treatment, because certain treatments may disqualify you from some clinical trials. You should only participate in clinical trials at reputable cancer centers that have obtained the necessary National Cancer Institute and FDA approvals.
If the results of a Phase I trial appear promising, the treatment will move into Phase II trials. If those look promising, then it's on to Phase III. If the Phase III trials show that the new treatment is safe and effective, its manufacturer can apply for FDA approval. To receive this approval, the drug manufacturer submits all the data it has collected from Phase I, II and III trials to the FDA. The FDA reviews the data to assess the treatment's safety and effectiveness. It can choose to reject the manufacturer's application, request more data, or approve the drug. If the drug is approved, the manufacturer can begin marketing it and doctors can start prescribing it. (Source: BreastCancerTrials.org)