De-Mystifying Clinical Trials—Debunking Common Myths

Every advance in breast cancer care has been the result of a clinical trial. But only 3 to 5% of women with breast cancer elect to participate in trials. Breast cancer clinical trials help us to learn and improve our care.

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If we didn’t test new treatments, we would still be doing disfiguring Halstead Radical Mastectomies, which, fortunately, were shown in trials not to be better for patients’ outcomes than simple mastectomy or lumpectomy (partial mastectomy).

Most people are not aware that there are hundreds of clinical trials now underway that are helping researchers develop new methods for preventing, detecting, and treating breast cancer and improving cancer patients' quality of life. But that's really not too surprising. Breast cancer clinical trials aren't the kind of thing you typically think about until you have a cancer diagnosis. And they aren't always easy to find.

To be sure, a clinical trial is not right for everyone. But there is little doubt within the cancer community that everyone will benefit if patients considering trial participation become the norm rather than the exception.


Patients' fears about experimental treatments, placebos, unnecessary testing, and cost of care often keep them from even considering a trial, let alone enrolling in one. Many of these fears are unfounded. For example, patients often think that every trial includes a group who will receive a placebo. But in cancer trials, that's not the case. Instead, patients who are assigned to control groups almost always receive standard treatment.


Yet, because these fears and concerns are so strong and so common, they can actually slow down the pace of cancer research. Why? If researchers don't have breast cancer patients who are interested in enrolling in clinical trials, they can't study new treatments. And unless they have data from good studies, the Food and Drug Administration will not approve new cancer treatments.


Every woman deserves the best quality care now and in the future—to bring us closer to that goal we need to change certain misconceptions surrounding trials. Here are a few persistent myths that keep many people in the dark about potential cancer treatments or preventive therapies:


Myth: Clinical trials are an option just used as a last resort

Fact: We learn how to improve all of our treatments for breast cancer through the process of clinical trials.

Clinical trials are a care option that all women should know about—they are not a last resort when all other treatments have failed. There are trials out there for screening, preventing, diagnosing, and treating breast cancer, and there are also trials for breast cancer survivors to help lessen the risks associated with recurrence.


Myth: Trial participants are “guinea pigs” for testing drugs

Fact: Drugs or devices that reach the clinic are thought to be as good as or better than the standard of care

Some women worry that clinical trials are testing unproven treatments on them. But any treatment offered in a trial must first show promising results in laboratory and animal studies before it can be approved for testing in people.

Women who participate in trials are not treated like guinea pigs. In fact, they are closely monitored by a research team and often receive extra attention during their care than women who are not participating in a trial.


Myth: There’s no way of knowing if you just getting a placebo

Fact: Women in trials receive the standard treatment or a treatment they think is better

If you choose to enroll in a trial for cancer treatment, you will not receive a placebo, or “sugar pill,” instead of proven therapy. You will either receive the best care currently available or a new, possibly more effective form of treatment.

With the advent of personalized medicine, doctors and scientists are creating therapies based on a patient’s individual genetic profile. No two cancers are exactly alike and there is no one-size-fits-all treatment, so clinical trials help develop a wide array of treatment options, allowing doctors to better match an individual’s biological make up to the most appropriate treatment.


Myth: Clinical Trials Aren’t Safe

Fact: Clinical trials are safe and they often provide more resources to take care of you

Clinical trials are a very regulated process. Clinical trials for new cancer treatments only get underway after there is evidence from laboratory studies (first in isolated cells and then in animals, like mice) that the treatment appears to work. The US Food and Drug Administration (FDA) then uses clinical trial findings, which report safety and effectiveness, to determine whether new treatments should be approved and integrated into routine care.


Talk to your doctor about whether or not a clinical trial may be right for you.


Myth: Clinical Trials Aren’t for Healthy People

Fact: Clinical trials can be for anyone

There are trials for people who don’t have cancer, but who may be at higher risk for getting cancer.  These are called “prevention trials,” and they help scientists study ways to reduce the risk of developing breast cancer. Most breast cancer prevention trials are conducted with healthy people who have not had cancer. Some trials are conducted with people who have had breast cancer and want to prevent the return of cancer or to reduce the chance of developing a new type of cancer. There are screening trials, and treatment trials (for all stages including DCIS), and quality of life trials.


Myth: You have to live near a large hospital in order to participate in a clinical trial

Fact:  Clinical trials are widely available

Many breast cancer clinical trials are conducted at local hospitals. Some also take place at local cancer clinics and doctor's offices.

The overwhelming demands of a breast cancer diagnosis can be daunting, whether you are high-risk, newly diagnosed, facing a recurrence, managing metastatic disease, or a long-term survivor. 


BreastCancerTrials.org, a website that profiles a broad range of breast cancer trials in user-friendly language, was inspired by two patient advocates who recognized that breast cancer patients needed an easier, more efficient way to identify the clinical trials that might be right for them. Visit the site to learn more.