Advanced Breast Cancer

Clinical Trials

Clinical trials offer many potential benefits, such as the opportunity for individuals with cancer to access cutting-edge treatments that are not yet widely available. In fact, many of the advances in cancer treatment are helping to save lives today because of the research conducted through trials. Depending on your diagnosis and other factors, such as if your cancer is not responding to treatment as well as expected, a clinical trial may be a valuable option, so it’s important to understand what it is and what it may mean for you.

Clinical trials are research studies that do the following:

  • Evaluate the safety and effectiveness of a medical strategy, treatment or device.
  • Develop a “standard of care” by helping identify which treatments work best for certain illnesses or groups of people.
  • Offer opportunities for people with cancer to help others by being involved in clinical research.

Clinical trials are sponsored (funded) by government agencies (such as the National Cancer Institute), independent groups of doctors and health care institutions, or the pharmaceutical or biotechnology industry. Once a treatment or device has been evaluated in clinical trials, the results are sent to the U.S. Food and Drug Administration (FDA). No treatment or device is made available for public use in the United States until the FDA reviews the results and grants its approval.

Types of Clinical Trials

There are three types of clinical trials: treatment trials; quality-of-life trials; and prevention, screening and diagnostic trials. The most common trials for individuals with advanced breast cancer are treatment and quality-of-life trials. In a treatment trial, researchers evaluate whether a new type of treatment (drug, surgery, radiation therapy) or a combination of treatments is better than the treatment options that are currently available. In a quality-of-life trial, researchers study to improve the quality of life, or the overall well-being of people during or after treatment.

What to Expect

When you volunteer to participate in a clinical trial, you will receive specific instructions and an Informed Consent form. You are encouraged to ask questions about anything you don’t understand before signing and returning the form. This is the ideal time to talk with your medical team about the many falsehoods that persist about clinical trials. For example, many people fear that they will receive a placebo instead of treatment, but all participants are guaranteed to receive, at minimum, the current standard of care during the trial.

Trials are carefully planned and performed in a consistent manner so that all patients are treated exactly the same, from the dose and schedule of the medication to the frequency of follow-up appointments. Institutional review boards or ethics committees carefully set up safeguards to make sure that all participants in the clinical trial remain safe throughout the process. Whether you’re at a small hospital or a large facility, your medical team will follow all of the same protocols and safety measures for your treatment plan. In addition to continuing to see your regular oncologist, you will also have a dedicated trial team closely monitoring you throughout the clinical trial. Even after the treatment ends, you will continue to be in close contact with the trial’s medical team.

Almost every type of cancer treatment has side effects, and the treatments used in clinical trials are no different. If you consider volunteering for a clinical trial, talk with your medical team about what you can expect so you are not surprised by any effects.

Participation is always voluntary, even after the study begins. If your expectations aren’t met or if you experience too many side effects, you can leave the trial at any time and return to standard of care treatment.

Cost is a common consideration with clinical trials. Routine patient care costs typically include those related to doctor visits and hospital stays. Some testing procedures that are part of standard care may be covered by your insurance. Research costs, which are directly related to the clinical trial and include drugs and procedures, are typically covered by the trial sponsor. Before dismissing the idea of participating because of the cost, search for resources and explore your insurance plan benefits. You may find that you can participate without a great deal of additional expense.

Your doctor or member of your medical team can give you more information about clinical trials in your area, but they may not be aware of all the trials available in other locations. A wide variety of online tools, including the resources below, are available to help you search for trials that may apply to you.

Find a Clinical Trial

Clinical Trials Myth vs. Fact

MYTH: Clinical trials are only for people who have no other options for treatment (a “last resort”).
FACT: Clinical trials of cancer treatment may be available for individuals with cancer of all types and stages.
 
MYTH: Clinical trials are not safe.
FACT: Clinical trials have many built-in safeguards to ensure that participants’ safety and rights are protected. These safeguards include an institutional review board, a data and safety monitoring board and an ongoing informed consent process.
 
MYTH: Clinical trials involve treatments with unknown safety and efficacy. 
FACT: Phase III clinical trials involve treatments that have been shown to be safe and effective in earlier phase trials. Phase III trials also include treatment with the standard of care, which has well-established evidence of safety and efficacy. Phase I and II trials are based on the results of preclinical trials showing the potential for efficacy and are carefully designed to ensure the safety of participants.
 
MYTH: Signing a consent form to participate “locks” you into staying in a trial.
FACT: Once you have signed a consent form, you are free to change your mind and not participate. You can also decide to drop out of a trial at any time for any reason.
 
MYTH: Some participants in a clinical trial will get a placebo (sugar pill) instead of treatment.
FACT: Participants in cancer clinical trials will receive the standard of care as a foundation and then the experimental treatment or a placebo will be added to it. Although rarely the case today, if a placebo is used, study sponsors are required to disclose this information to patients ahead of time so that patients can make an informed decision about participating.
 
MYTH: The cost of care in a clinical trial is not covered by health insurance.
FACT: Under the new health care laws, patient care costs (such as going to the doctor, any stays in the hospital or certain testing procedures) are covered by insurance. Research costs are those directly related to the study. It’s common, but not guaranteed, for the trial sponsor to cover these costs. Insurance does not typically cover research costs.
 
MYTH: Participants in clinical trials are treated like “guinea pigs.” 
FACT: The overwhelming majority of clinical trial participants (97 percent) say they were treated with dignity and respect; 93 percent report having a positive experience in the trial.
 
MYTH: Clinical trials only take place at large hospitals or cancer centers.
FACT: Many clinical trials are now done at local hospitals, cancer centers and doctors’ offices.
 
 

Questions to ask your doctor about treatment

  General questions
  • What are the results of tumor marker testing of my cancer (ER, PR and HER2 status)?
  • What treatment plan do you recommend? Why?
  • Are there any other treatment options available to me?
  • What is the goal of my treatment?
  • What are the possible side effects of this treatment?
  • How will this treatment affect my daily life and routine activities?
  • What clinical trials are open to me?
  Questions about hormone therapy
  • Which hormone therapy drugs can I take with my menopausal status?
  • What are the advantages and disadvantages of these drugs?
  • Which drug would be best for me? Why?
  • What are the possible side effects of this drug?
  Questions about chemotherapy and targeted therapy
  • What are the names of the drugs and how are they given?
  • Where will I receive treatment (in the doctor’s office, in a clinic)?
  • Will I need another person to help me get home after treatment?
  • How long will each treatment session last?
  • What is the difference between oral and IV medications?
  • What are the side effects of each drug?
  • What can be done to decrease these side effects?
  • What is the likelihood of resistance developing?

 

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