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Clinical Trials

 

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Clinical Trials
Fact Sheet

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Clinical Trials  

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Clinical Trials

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Research Fast Facts: Clinical Trials
Fact Sheet  

The importance of clinical trials  

Over the past 30 years, treatment of breast cancer has greatly improved due to lessons learned through clinical trials.  

Clinical trials test the safety and benefits of new treatments, diagnostic methods and screening tests. People volunteer to take part in these research studies. Whether a new therapy or test becomes part of standard treatment (or diagnosis or screening) for breast cancer depends largely on clinical trial results. For example, clinical trials showed the benefit of hormone therapies and trastuzumab (Herceptin) in breast cancer treatment and these drugs are now part of standard care. Large randomized clinical trials are viewed as the best basis for making treatment guidelines.  

Clinical trials take place across the country (and around the world) in many types of medical centers and hospitals. Often, trials are funded by a single agency like the National Cancer Institute (a government agency) and are carried out at the same time in many sites across the country. These are called cooperative group clinical trials, and they allow researchers to increase the number of people in a given study.  

Dedicated physicians, researchers and other health professionals, as well as hospitals, medical research centers and funders are all key to clinical trials. However, most important are the participants. These are the people willing to join clinical trials that will help further the knowledge base that ultimately helps improve breast cancer care.  

Types of cancer treatment trials

There are four main types of clinical trials that look at new breast cancer treatments:

  • Phase 1 (phase I) trials study whether a new treatment is safe to use over a range of doses. The treatment may be given to people with different types of cancers. A phase 1 trial is mainly a drug safety study.
     
  • Phase 2 (phase II) trials study how well a treatment works for a certain cancer, such as breast cancer. These trials may include between 25 and 100 people. After a drug (or other therapy) is found to be effective in treating breast cancer in a phase 2 trial, a phase 3 trial will study it further.
     
  • Phase 3 (phase III) trials study how well a new treatment (including surgical procedures) works compared to the standard treatment (standard of care). They study the best way to give the new treatment to get the most benefit and whether it is better than the current standard treatment. Phase 3 trials may look at different doses of the same drug, different drug combinations or different sequences of giving drugs (for example, studying which drug is best to give first). In phase 3 trials, people are randomized (chosen by chance) to get either the new treatment or the standard treatment. They do not get to choose which treatment they will get. This ensures the study results reflect the true benefits and risks of the new treatment. Not all clinical trials fall neatly into one category. Some trials may be a combination of two categories, such as a phase 1/2 or phase 2/3.
     
  • Phase 4 (phase IV) trials study the long-term side effects of treatments or answer new questions about the treatment. They are done after a new breast cancer treatment is approved by the U.S. Food and Drug Administration (FDA-approved).  

Benefits of clinical trials

If you have breast cancer, we encourage you to join a clinical trial. Clinical trials offer the chance to try new treatments and possibly benefit from them. Learning a new therapy is better than the standard treatment can also help others. And, as new therapies are developed, they can open doors to other drugs and procedures that may be even more effective.  

Some people worry they will get a placebo instead of an effective treatment in a clinical trial. However, placebos are not used in metastatic breast cancer clinical trials and are not commonly used in other cancer trials. Your health care provider or the clinical research staff can tell you if there is a placebo in the study. Most often in a breast cancer treatment clinical trial, you will get either the new treatment or the standard treatment. So, even if you do not get the new drug (or other new therapy), your breast cancer will be treated just as it would if you were not in the trial. Sometimes in a non-metastatic cancer trial, you may get standard treatment plus a placebo rather than standard treatment plus a new treatment.

Possible drawbacks of clinical trials

Location of clinical trials

Where you live may be a factor in choosing to join a clinical trial. Some clinical trials are done only in one (or a few) medical centers, while others are done in many locations across the country. There may not be a clinical trial that is right for in your local area.

Side effects

The risks of a new treatment may not be fully understood, so there may be some unexpected side effects. Though testing keeps these risks as small as possible, all the side effects of a new treatment are often not revealed until after long-term testing and follow-up.

Financial issues

New treatment or tests being studied are usually paid for by the clinical trial. Out-of-pocket costs for most clinical trials are the same as those for standard treatment.  

The Affordable Care Act (health care reform) now requires insurance companies to cover non-research, standard care costs related to a clinical trial (and not covered by the trial itself) plus any standard treatment given (learn more). Before enrolling in a clinical trial, talk with your insurance provider and find out exactly which costs are covered (and which are not). This ensures you do not have any unexpected costs, such as out-of-network fees.  

Some states require insurance companies to pay for certain costs related to being in a clinical trial. It is a good idea to check the laws in your state. The American Cancer Society’s Clinical Trials: State Laws About Insurance Coverage and the National Cancer Institute’s States Requiring Coverage of Clinical Trial Costs provide lists of these state laws.  

Clinical trials at the Clinical Center of the National Institutes of Health (NIH) in Bethesda, Maryland are free of charge to those who are eligible to join and willing to get treatment at the center. For more information on these studies, visit the NIH clinical center website or call 1-800-4CANCER.

Who can join a clinical trial

Though clinical trials usually study treatments, there are trials that focus on other areas of breast cancer, such as prevention and screening. These studies often look for women who have never had breast cancer to take part in the study.  

There are also many clinical trials for breast cancer survivors who are not undergoing active treatment. These trials may include studies of long-term effects of breast cancer treatments and studies of the survival benefits of lifestyle behaviors (such as diet and exercise). Learn more about ways for survivors to get involved in breast cancer research.  

All clinical trials have specific criteria for joining the study. For example, each trial will have a list of medical conditions that people must have (or not have) in order to join the study.

Learn more about eligibility criteria.  

Taking part in a clinical trial

When to consider joining in a clinical trial

If you are newly diagnosed with breast cancer, you should consider joining a clinical trial before starting treatment. For most people with early breast cancer, treatment doesn’t start right after diagnosis. So, there is time to find a clinical trial that might meet your needs as part of your treatment options. Once you have begun standard treatment for early breast cancer, it can be difficult to join a clinical trial.  

If you have a breast cancer recurrence, you should consider joining a clinical trial before treatment for recurrence begins or when your health care provider is considering changing treatments. If you are diagnosed with metastatic breast cancer, consider joining when your provider is considering changing treatments or before starting a new treatment.

Talking to your health care provider and clinical trial staff

Before you join a clinical trial, discuss the risks and benefits with your health care provider. There may be a research nurse or coordinator from the clinical trial who can give you more information about the study. See below for questions to ask your provider and/or the research staff about joining a clinical trial.  

Talking with friends and family is also helpful during your decision-making process.  

Eligibility

All clinical trials have guidelines (eligibility criteria) for who can join the study. These criteria vary from study to study and may be based on:

  • Type and stage of breast cancer
  • Past treatments for breast cancer
  • Other medical conditions

Most clinical trials are designed for select groups of people, so it is important to find a trial that fits your situation.

How to enroll

If you and your health care provider decide a clinical trial is a good option for you, your provider should put you in touch with a research nurse or coordinator from the trial. This person will guide you through the enrollment process.

Informed consent

Informed consent is the process of reviewing the risks, benefits and options for the study. It is required for all clinical trials. Before joining a trial, a research coordinator or nurse will go over the study protocol with you. The protocol describes in detail:

  • Reason/rationale for the study
  • Study design
  • Treatment regimen (what drugs or other therapies will be used during the trial)
  • What tests will be done (and how often the tests will be done)
  • What data will be collected
  • How many people will be in the study
  • Eligibility criteria (guidelines for who can join the study)

The research coordinator or nurse will answer any questions you have. Once you decide to join the study, you will be asked for your written permission. The document you sign is called a consent form and you will get a copy. This form includes the study protocol as well as the potential risks and benefits of the treatment or test.  

Remember that being in a clinical trial is voluntary. You may leave the trial at any time, for any reason. Consenting and giving written permission to join the study does not force you to stay in the study.  

Questions to ask your health care provider and the clinical trial research coordinator, nurse or physician

  

Questions to Ask Your Doctor about Clinical Trials
Topic Card

Before joining a clinical trial, talk to the research coordinator, nurse or physician from the study. This person can answer your questions and discuss any concerns you may have. You may want to take a friend or family member with you to help ask questions, take notes and give you support. Also, you may wish to record the discussion so you can review it later.  

It is a good idea to bring a list of questions and concerns. The following questions may be useful for your discussion.

  1. Why is this study being done?
  2. Who is sponsoring this study?
  3. Can I join?
  4. What are the potential risks and benefits of joining this clinical trial? What risks and benefits are most likely for me?
  5. What were the results of other studies on this treatment or technique?
  6. Who chooses which type of treatment or procedure I will have?
  7. Will I get a placebo?
  8. What tests or treatments are involved?
  9. How do the tests and treatments in this study compare to those in standard care?
  10. How often do I need to come in for treatment and testing?
  11. What medical expenses will be paid by the clinical trial? Will my insurance cover the remaining costs or will I need to pay for them myself?
  12. Where is this study being done?
  13. How long will I be in the study?
  14. What happens when the study ends? Is there long-term follow-up care? If the treatment is working for me, can I continue to get it after the study ends?
  15. What happens if I am harmed somehow in the study? Is medical care provided and paid for by the study?
  16. Is there a person already enrolled in the study that I can talk to?
  17. How will my personal information be protected in this study?
  18. Who can I contact if I have more questions?
  19. Are there other clinical trials I should consider that might offer more benefit for me?

(Adapted from American Cancer Society and National Cancer Institute materials [143-144]).  

Who sponsors clinical trials

Most clinical trials are funded by the National Cancer Institute (NCI), a part of the National Institutes of Health (NIH). NCI also sponsors groups that study the same cancer topic, such as the American College of Radiology Imaging Network. These groups include many hospitals, universities and physicians who work together to study certain cancer issues.  

The Department of Defense and the Department of Veterans Affairs are other government sources of funding for clinical trials. Pharmaceutical and biotechnology companies and nonprofit organizations also sponsor clinical trials.  

Where to find a clinical trial

BreastCancerTrials.org in collaboration with Susan G. Komen® offers a custom matching service that can help you find a clinical trial that fits your health needs.  

The following websites offer more information on clinical trials and help in finding a clinical trial.  

BreastCancerTrials.org
www.breastcancertrials.org  

CenterWatch clinical trials listing service
www.centerwatch.com/  

Coalition of Cancer Cooperative Groups
www.cancertrialshelp.org/ 

ECancerTrials.com clinical trials matching and referral services
www.ecancertrials.com/  

National Cancer Institute (NCI) clinical trials website 
www.cancer.gov/clinicaltrials/  

National Institutes of Health (NIH) clinical trials websites
www.cc.nih.gov/
www.clinicaltrials.gov/    

 Komen Perspectives  

Read our perspective on clinical trials (July 2012).* 

 

 Komen Support Resources  

  • Our breast care helpline 1-877 GO KOMEN (1-877-465-6636) provides free, professional support services and help finding local support groups. Our trained and caring staff are available to you and your family Monday through Friday from 9:00 a.m. to 10:00 p.m. ET and from 6:00 a.m. to 7:00 p.m. PT.
     
  • Our Message Boards offer online forums for breast cancer survivors to share their experiences and advice with other breast cancer survivors. There is a special forum for people participating in (or considering joining) a clinical trial.
 


*Please note, the information provided within Komen Perspectives articles is only current as of the date of posting. Therefore, some information may be out of date at this time.    

Updated 04/25/14

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