Clinical Trials

As a university-based cancer center, the Braman Family Breast Cancer Institute at UM/Sylvester offers patients access to the latest breakthroughs for treating cancer.Patients benefit from life-saving discoveries in the laboratory, which are then applied to their treatment.

You may be offered the chance to take part in a clinical trial at some time during your treatment.Clinical trials, which are research studies used to answer specific questions about new therapies or new ways of using known therapies, allow patients to participate in the newest treatments in development.Clinical trials also may be used to compare diagnostic tests, prevention strategies, or other aspects of caring for cancer patients.

Clinical trials are done in several stages

• A phase I clinical trial aims to find the best and safest way to give a new treatment. Patients are closely watched for side effects.Once the phase I trial is completed, the new treatment may be evaluated in a phase II clinical trial.
• A phase II clinical trial is one in which doctors are looking for significant anti-cancer activity, and determining the medication’s side effects.
• A phase III clinical trial will compare the new treatment to a standard treatment, randomly assigning patients to either group.Random assignment means assignment is based on chance, similar to flipping a coin.This makes the results of the trial more scientifically sound.

You may be asked to take part in any of these three types of clinical trials. Some people worry they will receive only a placebo (such as an ineffective sugar pill) in a clinical trial, but that is very rarely done in cancer treatment clinical trials, and these types of trials are not conducted at UM/Sylvester. 

Studies indicate patients who participate in clinical trials have a significantly better outcome than those who do not. If you choose to participate in a trial, you can help evaluate new treatments, and also may have access to new therapies that are not yet available to the general public.However, you are not required to participate in a clinical trial, and, if you refuse, it will not jeopardize your relationship with your physician.You may leave a trial at any time, for any reason--even after signing the agreement.

If you are asked to participate in a clinical trial, your doctor or nurse will explain exactly what is involved and any known benefits or drawbacks posed by the trial.You will need to sign an informed consent agreement before enrolling in a clinical trial at UM/Sylvester.

For more information about clinical trials at the Braman Family Breast Cancer Institute and UM/Sylvester’s Clinical Trials Matching Service for breast cancer patients, click here.