Clinical Trials

Clinical trials are the single most important means of advancing knowledge and improving treatment for all forms of cancer.  A clinical trial is research that compares the existing best available treatment to a promising new treatment. Clinical trials are done to establish whether a new treatment is safe and effective.  They can involve a new drug, a new combination of drugs, a new approach to radiation therapy or surgery, or a new combination of several existing treatments.  Clinical trials develop better ways to manage symptoms to improve quality of life.  Clinical trials are NOT just for patients who are in the end stages of their disease.  Hundreds of clinical trials are underway in the United States and throughout the world.  They address every stage and type of breast cancer and other diseases.

If no standard of care has been established, the new treatment may be compared to a placebo, or inactive substance.  Since so many treatment options are available to treat all stages of breast cancer, most breast cancer clinical trials do not involve placebos.  Every clinical trial is very carefully reviewed and approved by the institutional review board (IRB) of the sponsoring cancer center.  Any patient who enrolls in a clinical trial must participate in a process known as informed consent.  This very detailed process explains the trial, its purpose, its potential benefits and risks, and what will be required of the patient.

Clinical trials are very carefully designed and structured to assure that the results are valid and can be legitimately compared to other studies of similar issues.  Every trial has eligibility criteria – meaning that the investigators are looking for patients with specific characteristics.  These can include the type of breast cancer, its stage, the overall health of the patient and any previous treatment.

Clinical trials also have very specifically designed end points by which the success or failure of the trial is measured.  The most common end points for clinical trials are:

• Overall Survival (OS), which measures whether people in the experimental arm of the trial live longer than those receiving the standard treatment.
• Progression-Free Survival (PFS), which measures whether people in the experimental arm have a longer time in which their cancers do not grow or progress than those receiving the standard treatment.
• Disease-Free Survival (DFS), which measures the length of time the experimental group remains disease-free compared with those who receive standard treatment.  In some instances, cancer treatments are given to patients who have no sign of disease, including those who receive adjuvant therapy after treatment of the primary tumor and patients who are in complete remission following another form of cancer treatment. 

We must be aware that results of clinical trials are generally expressed in statistics that apply to an entire group of patients being treated, not to individuals.  Individual patient responses in clinical trials are usually either better or worse than average.  If one arm of a clinical trial is clearly showing better results, the trial is often stopped, or patients are allowed to "cross over" from the treatment that is not working as well to the one that is.

The benefits of participating in clinical trials for eligible patients are significant.  Clinical trials are usually conducted in leading cancer centers.  They provide access to the most current treatments where finding better ways to treat breast cancer is emphasized.  Patients on clinical trials receive high levels of care for all aspects of their disease.  If you participate in a clinical trial, you know that you are contributing to research and helping to improve treatment for future patients.

Insurance coverage for clinical trials can be an issue of concern.  Coverage varies significantly from state to state and plan to plan.  Discuss insurance with your treatment team if you are interested in participating in a clinical trial.
 

For more information on breast cancer related clinical trials, call the Y-ME Hotline at 1-800-221-2141.