Clinical trials are one of the final stages of a long and careful cancer research process. They can only take place after satisfactory information has been gathered from laboratory research, including cell cultures and animal models. Even the most promising scientific findings must first be proven to be safe and effective in clinical trials before they can be used as standard treatment. The cancer treatments that are used today were developed and tested in clinical trials. Through our research grants, we have supported more than 500 clinical trials.
Our trials examine a broad range of areas:
Learn more about what Komen is doing to help people with any stage of breast cancer find and
participate in clinical trials.
We support clinical trials in all areas of
the breast cancer research continuum, from prevention and early detection, to
diagnostic, treatment and survivorship trials.
There are several types of
Breast cancer treatment trials test new treatments, such as a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments or new methods such as gene therapy or cancer vaccines.
Breast cancer prevention trials test new approaches, such as medicines, vitamins or lifestyle interventions that may lower the risk of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back in people who have already had cancer.
Breast cancer screening trials test the best way to detect cancer, especially in its early stages. In some cancers, finding cancer early can improve the results of treatment and increase the chances of survival. Screening trials may study new medical imaging methods or a new type of blood test, called biomarkers, which would detect cancer clues.
Breast cancer diagnostic trials test new ways of differentiating between different subtypes of cancer, predicting the outcome of a particular cancer, or predicting whether a cancer will respond to a specific therapy. Like screening trials, diagnostic trials may study new medical imaging methods or biomarkers.
Quality of life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for cancer patients and survivors. These trials may look at better ways to prevent or manage nausea, fatigue, depression, pain or other problems caused by cancer or its treatment. They may also test methods for communicating or educating people about breast cancer and breast health.
In these types of trials, there is generally no intervention. Researchers only observe groups of people or collect information from them to determine who may be at increased risk for breast cancer, to identify the causes of breast cancer or to identify lifestyle factors that may contribute to breast cancer risk.
Most clinical research progresses through an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information, yet protects patients. Most clinical trials are classified into one of three phases:
These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often and what dose is safe. A phase I trial usually enrolls only a small number of patients.
A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works.
These studies test a new drug, a new combination of drugs or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at doctors' offices, clinics and cancer centers nationwide.
After a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
Clinical trials offer a way for women with breast cancer to play an active role in their own health care, gain access to new research treatments before they are widely available, obtain expert medical care at leading health care facilities during the trial and help others by contributing to medical research.
Learn more about the benefits to participating in clinical trials.
If you‘re thinking about taking part in a clinical trial, it’s important to be informed and ask the right questions. Before joining a clinical trial, talk to the research coordinator, nurse or physician from the study. This person can answer your questions and discuss any concerns you may have. You may want to take a friend or family member with you to help ask questions, take notes and give you support.
For more information and some questions you might want to ask, download one of our “Questions to Ask Your Doctor” discussion guides.
If you and your health care provider decide a clinical trial is a good option for you, your provider should put you in touch with a research nurse or coordinator from the trial. This person will guide you through the enrollment process. You can also visit resources like breastcancertrials.org to find the trial that’s right for you.
Learn more about how Komen awards scientific research grants.
With your help, Komen researchers are making a difference.
Breast cancer survivors and advocates are involved in our scientific research.
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