The decision to enroll in a clinical trial should involve a discussion between the person with breast cancer and that individual’s physician. Participation in a trial will depend on many factors, including the motivation for enrolling in a trial, the type of breast cancer, the trials available, and the stage of the breast cancer.
Different Types of Breast Cancer Studies
There are many different reasons as to why researchers conduct breast cancer clinical trials. These can include:
- Testing a therapy, such as a drug or other medical intervention, for treating existing breast cancer. These are known as interventional trials.
- Finding ways to stop the development of breast cancer, for example through lifestyle changes, diet or medications. These are called prevention trials.
- Evaluating ways to better diagnose breast cancer. These are referred to as diagnostic and screening trials.
- Studying breast cancer in a large group of people to better understand it as a health issue. This is known as an observational trial or a non-interventional study.
- Examining ways to improve the comfort and quality of life for people with breast cancer. These are often called supportive care trials or quality of life trials.
In the case of new treatments (interventional trials), three separate trial phases are required by U.S. Food and Drug Administration (FDA), or if the trial is not in the United States, those phases are required by the equivalent governing bodies of the country the trial is being conducted in.
Some Current Areas of Breast Cancer Interventional Studies
Interventional trials are the most common type of clinical trial in which participants with breast cancer will be involved. Medical researchers are now studying several new promising areas in the field of breast cancer research.
New chemotherapy approaches involve examining new drugs and in some cases drug combinations to treat the existing cancer. Scientists are developing biological therapies that interrupt the molecular processes that tumors require to grow. Immune therapies can involve boosting the body’s immune system so that it can better fight off cancer. Tumor-directed treatments actually target the cancer cells themselves, and are aimed at killing the cancer cells while minimally affecting the body. Stem cell transplant is another approach currently being used to treat breast cancer and being improved upon through research. This can involve allogeneic transplantation (from another person) or autologous transplantation (from one’s own blood-forming stem cells).
Phases of Interventional Trials
Interventional trials are the most common type of clinical trial. If you or someone you know is involved in an interventional clinical trial, knowing the phase of the trial can tell you more about what is involved.
Phase I testing is the first step in humans. The purpose is to determine safety and to evaluate side effects. Phase I studies also test how the drug is absorbed, distributed and eliminated from the body. Often people who do not have the disease (healthy individuals) participate in Phase I. The number of people involved at this stage is usually small.
Phase II trials are sometimes divided into Phase IIA and Phase IIB. Sometimes these two sub-phases are combined. Phase II trials further assess dosing and are designed to determine the best drug dose to use and how much of a dose is safe. Phase II studies can also measure efficacy and safety testing in small numbers of participants. Often a treatment must pass Phase II in order to proceed to Phase III.
Most reports of medical treatment studies focus on Phase III trials. These are the large trials that are required for a drug or other treatment to receive approval for use. The purpose of this phase is to test efficacy and safety as well as to monitor for side effects. The main drug effects are often called the primary efficacy endpoints. Other measurements may be called the secondary endpoints.
Sometimes researchers conduct Phase IV trials, after a drug has been approved. These trials collect additional information about the drug or treatment.
Where to Find Out About Breast Cancer Clinical Trials
There are several sources that can be accessed to find out more about the breast cancer studies currently going on today. These include the National Cancer Institute (www.cancer.gov/clinicaltrials) or the National Institutes of Health Clinical Trial Resource (www.clinicaltrials.gov). CenterWatch is another organization that connects people with clinical trials and is available at http://www.centerwatch.com/.
Be sure to continue to follow our ongoing series into breast cancer clinical trials — exclusively at Breast Cancer News. Our next article will explore the topic of Reasons to Participate in a breast cancer Clinical Trial.