Understanding Clinical Trials

If you are interested in enrolling in a clinical trial, talk to your doctor about what may be right for you. Below you will find some background information about clinical trials that may help inform your discussion with your doctor.

Understanding Clinical Trials

A clinical trial is a carefully designed research study in which people participate as volunteers to test new methods of screening, preventing, diagnosing, or treating breast cancer. Clinical trials are also referred to as clinical studies, medical research, and research protocols. Carefully conducted clinical trials are the safest and most effective way to find new methods of preventing, diagnosing, and treating breast cancer.

Clinical trials are a very regulated process. Clinical trials for new cancer treatments only get underway after there is evidence from laboratory studies (first in cells and then in animals like mice) that the treatment appears to work. The US Food and Drug Administration uses clinical trial findings, which report safety and effectiveness, to determine whether new treatments should be approved and integrated into routine care.

There are also opportunities to be in studies to help scientists learn about who is going to develop what kind of cancer. These are called observational studies and do not involve any type of experimental drug or intervention. Instead, study participants are observed over time. The Sister Study, for example, is a long-term observational study of women whose sister(s) had breast cancer that is investigating environmental and genetic factors that affect a woman's chances of getting breast cancer.

In the future, care delivered through the process of screening and breast cancer treatment should be integrated with the ability to better educate our patients about all of their risk factors and options, and to make sure we have the opportunity to constantly improve what we do—FASTER!

Questions for My Doctor

Your doctor and the other members of your medical team can help you weigh the risks and benefits of having any treatment and you should ask if there are trials or studies in which you can participate.  The decision to have any treatment is totally up to you.

Remember: You should feel free to ask any question or bring up any concern with your doctor or with members of the research staff.

If you find that your doctor is, in general, unreceptive to the idea of answering questions or discussing clinical trials, or has concerns about your entering a specific clinical trial, you may want to consider seeing another doctor for a second opinion.

When you have to face a decision about having a biopsy, treatment for DCIS or invasive cancer, there are some questions you may want to ask your doctor.

If you are told you are being called back for an abnormal mammogram, remember that most of the time, no cancer will be found. If you have to face a decision about a biopsy, ask your doctor whether the risk is very low (in the 2-10% range) or much higher. Ask whether they are worried about invasive cancer or DCIS. If the risk is low, and they are mostly worried about DCIS, you might want to ask if there is an option to have close surveillance and come back in 6 months. Make sure they have compared your current image to your last one (what they are seeing now might have been there in the past and you might not need a biopsy)

If you are told you have DCIS, sit down with your physician and discuss all the options, including clinical trials. You should know that the decisions you make are not about life or death, but about the risk of developing a cancer down the line. We have learned that lumpectomy alone is safe for many patients. Have a thorough discussion with your doctor, and don’t feel rushed to make a decision!

If you have invasive cancer, you should also take the time to discuss all of your options. Your tumor may be very low risk, in which less treatment can be safe. If your doctor cannot tell you about the risk, ask about molecular tests such as MammaPrint or oncotype Dx as the results may make a big difference in helping you decide which treatments may be right for you. While breast cancer treatment often starts with surgery, sometimes it is better not to.  If your tumor is on the large side, you should ask about starting first with the treatments that affect your whole body (hormone therapy or chemotherapy) as they may shrink your tumor, help you learn about how effective the treatments are, and change the type of surgery you need. There are also many opportunities for clinical trials.

If you are thinking about participating Clinical Trial, ask your doctor:

  • What do you know about this trial?
  • What should I ask the trial coordinator?
  • Do you have other patients who have enrolled in this trial?
  • Are there other trials besides from this one that I should consider?
  • What would my treatment be if I didn't enter the trial?

Risk and Benefits

  • What are the possible short-term benefits?
  • What are the possible long-term benefits?
  • What side effects might I experience?
  • Are there treatments to alleviate side effects?
  • Are there any potential long-term risks?
  • How do the potential benefits compare to other treatment options?
  • How will the trial and its possible side effects affect my daily life?

Trial Participation Requirements and Care

  • What tests, procedures, and treatments will I have during the trial?
  • How do these tests, procedures, and treatments differ from those I would have if I didn't take place in this trial?
  • Where will these tests, procedures, and treatments be done?
  • Will I still see you - my own doctor - on a regular basis?
  • Who will monitor my care and safety?

Tips for Talking to Your Doctor

  • Consider having a friend or family member with you to take notes or help ask questions.
  • Consider recording the conversation so you can review the answers at a later date.
  • Prepare your questions in advance, and write down your doctor's answers.
  • Tell your doctor if you are having trouble understanding an explanation, description, or unfamiliar word.

Some of the information in this article is used or adapted with permission from "Questions to Ask Your Doctor" by the Coalition of Cancer Cooperative Groups.

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