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NCCN Guidelines for Patients



Breast Cancer – Metastatic (STAGE IV), Version 2.2017

Clinical trials

One of your treatment choices may be to join

a clinical trial. Joining a clinical trial is strongly

supported. NCCN believes that you will receive the

best management in a clinical trial.

New tests and treatments aren’t offered to the

public as soon as they’re made. They first need to

be studied. A clinical trial is a type of research that

studies a test or treatment in people.

Clinical trials study how safe and helpful tests and

treatments are for people. When found to be safe

and helpful, they may become tomorrow’s standard

of care. Because of clinical trials, the tests and

treatments in this book are now widely used to

help people with breast cancer. Future tests and

treatments that may have better results than today’s

treatments will depend on clinical trials.

New tests and treatments go through a series of

clinical trials. These trials aim to ensure they’re safe

and work. Without clinical trials, there is no way to

know if a test or treatment is safe or helpful. Clinical

trials have four phases. Some examples of the four

phases for treatment are:



Phase I trials aim to find the safest and best

dose of a new drug. Another aim is to find the

best way to give the drug with the fewest side

effects. These trials often involve about 20




Phase II trials assess if a drug works for a

specific type of cancer.



Phase III trials compare a new drug to a

standard treatment. These trials often involve

hundreds or thousands of people.



Phase IV trials test drugs approved by the U.S.



ood and




dministration) to learn

more about side effects with long-term use.

Joining a clinical trial has benefits. First, you’ll have

access to the most current cancer care. However,

please note that it is unknown how well new

treatments work if at all. Second, you will receive the

best management of care. Third, the results of your

treatment—both good and bad—will be carefully

tracked. Fourth, you may help other people who will

have cancer in the future.

Clinical trials have risks, too. Like any test or

treatment, there may be side effects. Also, new

tests or treatments may or may not improve your

health. In fact, your health may worsen during a trial.

Other downsides may include more hospital trips,

paperwork, and extra costs for you.

To join a clinical trial, you must meet the conditions

of the study. Patients in a clinical trial are often alike

in terms of their cancer and general health. Thus, if

patients improve, it’s because of the treatment and

not because of differences between them.

To join, you’ll need to review and sign a paper called

an informed consent form. This form describes the

study in detail. The study’s risks and benefits should

be described and may include others than those

described above.

Ask your treatment team if there is an open clinical

trial that you can join. There may be clinical trials

where you’re getting treatment or at other treatment

centers nearby. You can also find clinical trials

through the websites listed in Part 4.


Treatment guide