A: Dr. Douglas Marks: Great question. Medical oncology clinical trials can involve enhanced diagnostic testing, medical treatments and lifestyle interventions. They are often a preferred method of providing care for patients. I routinely consider clinical trial options for my patients, even if FDA-approved treatment options exist, if I believe the trial provides access to a promising innovative diagnostic test or a new drug combination that is likely to be superior to standard therapy. Clinical trials frequently include drugs that are either already approved in breast cancer (or other cancer types) that are being evaluated in combination with different drug partners. That said, clinical trials do also play a very important role in providing treatment options for patients who have exhausted FDA approved clinical options as well.
Not every trial is appropriate for every patient, and your doctor should advise you that these studies represent diagnostic or treatment options that are in development and the risk/benefit ratio is not always certain. Your doctor should also be willing to discuss the existing data that supports the potential benefit of the clinical trial for you specifically.
Dr. Nina D’Abreo: I agree, with Dr. Marks. Clinical trials are one of the main vehicles for offering patients therapy that have promising efficacy prior to being FDA approved. Your doctor should let you know the “phase” of the clinical trial as there are multiple “phases”. Phase 0 or Phase I trials represent the earliest stage in drug development. These trials typically aim to assess a new drug’s (or drug combinations) safety or early effectiveness. Phase II trials are designed to evaluate a drug’s effectiveness, which is often confirmed later in a Phase III trial when compared to another currently approved treatment option. At NYU Winthrop Hospital we have trials for patients with early stage (Stages I-II), locally advanced (Stage III) as well as advanced/metastatic breast cancer (Stage IV).