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What Are Clinical Trials?

Clinical trials for triple-negative breast cancer

Clinical trials are health-related research studies to evaluate investigational medical treatments and therapies in people. Pharmaceutical and biotechnology companies must conduct clinical trials to determine whether a medication is safe and effective and must submit this data to regulatory authorities (e.g., the FDA in the United States; Health Canada in Canada) for approval before making the medication available to the public. A clinical trial involves testing an investigational product in a carefully selected group of volunteers; hundreds of participants are needed to test investigational products. All clinical trials are closely monitored by regulatory and ethics committees, and study doctors closely follow the progress of each participant.

Before an investigational treatment is tested in people, it is studied in a laboratory. If a treatment has promising laboratory results, it goes into clinical trials for further testing. Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Improved treatments and therapies for diseases such as triple-negative breast cancer could not be found without clinical trials. What is learned from clinical trials helps doctors develop better treatment options for patients. For a better understanding of clinical trials, please visit clinicaltrials.gov.

The METRIC Study– A Clinical Trial of Glembatumumab vedotin (CDX-011) in Metastatic Triple-Negative Breast Cancer Over-expressing gpNMB

Doctors are conducting the METRIC Study to evaluate the safety and effectiveness of glembatumumab vedotin (CDX-011) in patients diagnosed with triple-negative breast cancer that has spread to other parts of the body. More than 250 patients with breast cancer or melanoma have received glembatumumab vedotin in prior research studies. Study results in both types of cancer support further testing of glembatumumab vedotin, particularly in patients with triple-negative breast cancer. If you have been diagnosed with triple-negative breast cancer that has spread beyond the original tumor, we hope that you will consider learning more about the METRIC Study.

Volunteering for the METRIC Study in Triple-Negative Breast Cancer Over-expressing gpNMB

If you are interested in learning more about the METRIC study, please visit clinicaltrials.gov for a listing of study locations and their contact information. When you contact a study location, they will ask you some questions to see if you meet the basic criteria required to participate. If you do, they will set up an appointment for a more thorough screening and answer any questions you may have.

Choosing to participate in a study is an important personal decision. Before making a decision to pursue participation in a clinical trial, talk with your doctor or other health care professional, family, caregivers and friends.

If you are eligible for the trial and choose to participate, your health will be followed closely by a METRIC study doctor and you could make an important contribution to triple-negative breast cancer treatment research that may one day change the way the condition is treated.

Thank you for your interest in the METRIC Study for patients with triple-negative breast cancer over-expressing gpNMB.

To find a study location near you, please visit clinicaltrials.gov.