Why We Need Clinical Trials for Breast Cancer

Why We Need Clinical Trials for Breast Cancer

Clinical trials are extremely important scientific studies needed and required to assess new medical treatments, including treatments for diseases like breast cancer. This article explores the reasons why clinical trials are necessary, what exactly they are, and how people with breast cancer can benefit from clinical trials.

Improved Breast Cancer Survival Rates

According to the American Cancer Society, improved treatment options are improving a patient’s chances of surviving breast cancer. Currently, the five-year relative survival rate for women who have either stage 0 or stage 1 breast cancer is close to 100%. Later-stage breast cancer has a lower survival rate, but it is still high: For women with stage 2 breast cancer, the five-year relative survival rate is about 93%, while for stage 3 breast cancers it is about 72%.

Continued Need for New Treatments

Despite successes in treatment, breast cancer remains one of the most common cancers in women worldwide, and continues to be fatal — particularly if the disease spreads to other parts of the body. According to the Centers for Disease Control and Prevention (CDC),  224,147 women and 2,125 men were diagnosed with breast cancer in the U.S. in 2012, and 41,150 women and 405 men died from the disease (statistics compiled by the U.S. Cancer Statistics Working Group in the report, United States Cancer Statistics: 1999–2012 Incidence and Mortality Web-based Report.)

These statistics bear out the continued need for improved therapeutics, which can only be developed, tested, and approved after rigorous clinical trials. Breast cancer patients are needed to help advance research and the development of new treatments.

Clinical Trials for Breast Cancer Explained

Clinical trials are well-designed studies that collect information about potential treatments for diseases and disorders. Most of the time this means medications, but clinical trials can also test other things, such as stem cell therapies, surgical techniques, tests for diagnosis, or medical devices. In particular, clinical trials focus on administering an experimental therapy in humans, as opposed to animals. Animal testing — or the testing on cells in a dish (in vitro) — is conducted first in the lab and is typically referred to as pre-clinical research, or research occurring before a clinical trial involving patients begins.

Clinical Trials Are Required for the Approval of New Treatments

What exactly is it that makes a clinical trial so necessary? Can’t doctors just start using a medication based on any study that shows it is effective? The answer to this is, of course, no. Clinical trials are necessary for medical treatments to be approved by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA). Without carefully designed and performed clinical trials, doctors and other healthcare providers (such as nurse practitioners or physician assistants) cannot prescribe medications or recommend other medical treatments. These studies are needed to understand two important types of information: 1) that the treatment is effective (also called efficacious), i.e., that it really works, and 2) that the treatment is safe for use in humans.

Clinical Trials Advance Scientific Knowledge, Assure Efficacy & Safety

In addition to helping patients by making the best possible treatments available, clinical trials also advance scientific understanding of a disease or disorder.

It is important to make sure that a new drug is more effective than existing treatments, actually works in a disease, and that it is safe. Decisions to give drugs or other medical treatments have to come from scientific data, not just the opinion of a healthcare provider, patient, or other individual. Clinical trials help to assure all of these things.

Despite successes in the treatment of breast cancer, new treatments — and new studies — are needed, and likely will be until a cure is found. Clinical trials are a necessary mechanism that can help advance research, and they are legally required step for new treatments to advance and potentially be approved for use by physicians and their patients.

Be sure to stay tuned to our exclusive, ongoing series of articles on clinical trials for breast cancer — exclusively at Breast Cancer News. Our next article will explore how breast cancer clinical trials work, and what you need to know about how they are managed and what they seek to accomplish.


  1. http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-survival-by-stage
  2. http://www.cdc.gov/cancer/breast/statistics/

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