Over the past 20 years, treatment of breast cancer has greatly improved, due to lessons learned through large clinical trials. Clinical trials test the benefits of new treatments, diagnostic procedures or screening techniques. People volunteer to take part in these research studies. Whether a new therapy or test becomes part of standard treatment, diagnosis or screening for breast cancer depends largely on clinical trial results. Large randomized clinical trials are viewed as the best basis for making treatment recommendations.
Clinical trials take place across the country (and around the world) and 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 participants in a given study.
Types of Cancer Treatment Trials
There are three main types of clinical trials that look at emerging breast cancer treatments (some studies may span more than one category):
- Phase 1 (phase I) trials study whether a new treatment is safe to use over a range of doses and is given to people with a variety of cancers. It is mainly a drug safety study.
- Phase 2 (phase II) trials study how well a treatment works for a certain cancer. These trials may include between 25 and 100 participants.
- Phase 3 (phase III) trials study how well a treatment (or surgical procedure) works compared to a standard treatment. In Phase 3 studies, participants are randomized by chance to get either the new treatment or the standard treatment. Participants do not get to choose which treatment they will get. These trials often include large numbers of people (more than phase 2 trials).
After a drug (or procedure) is found to be effective in treating breast cancer in a phase 2 trial, a phase 3 trial will study it further. A phase 3 trial studies the best way to give the drug 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 or different drug combinations or sequences of giving drugs (for example, studying which drug is best to give first). Although a phase 3 trial may sound “better” or less risky than a phase 2 trial, this is not necessarily true. You may get just as much benefit from a treatment in a phase 2 trial as you would in a phase 3 trial. Even though a phase 3 trial may have more participants than a phase 2 trial, the treatments may be the same. This is especially true if the clinical trial is testing a new technique rather than a new drug. Not all clinical trials fall into one category. Some trials may be combination of two categories, such as a phase 1/2 or phase 2/3.
After a new breast cancer treatment is FDA-approved, there may be further clinical trials. These are called phase 4 (phase IV) trials and they look at the long-term side effects of treatments or answer new questions about the treatment.
Benefits of Clinical Trials
If you have breast cancer, you should consider participating in a clinical trial. Clinical trials offer the chance to try new treatments and possibly benefit from them. And, these benefits extend far beyond the people who are enrolled in the trial. Learning that a new treatment is better at treating breast cancer can help many others. As new therapies are developed, they can open doors to other drugs and procedures that may be even more effective.
Some people worry that if they are in a clinical trial they will get a placebo instead of an effective treatment. However, this is not true. Most often, if you participate in a clinical trial you will receive either the new treatment or the standard treatment. Therefore, 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.
Participating in a Clinical Trial
When to consider participating in a clinical trial
If you are newly diagnosed with breast cancer, you should consider taking part in a clinical trial before starting treatment. If you are a breast cancer survivor and have a recurrence, you should consider enrolling before treatment for recurrence begins or when your health care provider is considering changing treatments. Once you have begun standard treatment for a new breast cancer or recurrence, it can be difficult to join a clinical trial.
Where you live may be a factor in choosing to participate in a clinical trial. Some clinical trials are done only in one or a few hospitals/clinics, while others are done in many locations across the country. Living near a participating institution may affect your decision to enroll.
Before you join a clinical trial, it is important to discuss the risks and benefits with your health care provider. There may also be a research nurse or coordinator who can give you more information about the study. See below for questions to ask your health care provider and/or the research staff about participating in 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. Studies may have criteria based on type and stage of breast cancer, prior treatment or other medical conditions.
Financial issues
Before enrolling in a clinical trial, you may want to make sure any costs not covered by clinical trial itself will be covered by your insurance. In most cases, insurance companies are expected to cover the non-research, standard care costs related to a clinical trial plus any standard treatment given. New treatment or tests being studied are normally paid for by the clinical trial.
The cancer-related 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.)
Some states require insurance companies to pay for certain costs related to participating 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 Regarding Insurance Coverage and the National Cancer Institute’s States That Require Health Plans to Cover Patient Care Costs in Clinical Trials provide lists of these state laws.
How to enroll
If you and your health care provider decide that a clinical trial is a good option for you, your health care provider should put you in touch with a research nurse or coordinator from the clinical 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 and is required for all clinical trials. Before joining a trial, a research coordinator or nurse will go over the study protocol. The protocol describes in detail:
- the reason/rationale for the study
- the study design
- the treatment regimen (what drugs or other treatment 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
- the eligibility criteria
The research coordinator or nurse will then answer any questions that 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 your participation 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 research coordinator/nurse (or research physician) of the clinical trial
Before joining a clinical trial, you should talk to the research coordinator/nurse (or research physician) of 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 that 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.
- Why is this study being done?
- Who is sponsoring this trial?
- Am I eligible to participate in this study?
- What are the potential risks and benefits of my participating in this trial? What risks and benefits are most likely for me?
- What were the results of other studies on this treatment or technique?
- Who chooses which type of treatment or procedure I have in the trial?
- Will I get a placebo?
- What tests or treatments are involved in this study?
- How do the tests and treatments in the study compare to those with standard care?
- How often do I need to come in for treatment and testing?
- What medical expenses will be paid for by the clinical trial? Will my insurance cover the remaining costs or will I need to pay for them myself?
- Where is this study being done?
- How long will I be in the study?
- 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 trial is over?
- What happens if I am harmed somehow in the study? Is medical care provided and paid for by the study?
- Is there a person already participating in the study that I can talk to?
- How will my personal information be protected in this study?
- Who can I contact if I have more questions?
- Are there other clinical trials that I should consider that might offer more benefit for me?
(Adapted from American Cancer Society and National Cancer Institute materials [118,119]).
Who sponsors clinical trials
Most clinical trials are funded by the National Cancer Institute (NCI), a part of the National Institutes of Health (NIH). The NCI also sponsors groups that study the same cancer topic, such as the American College of Radiology Imaging Network. These groups include many hospitals, academic institutions 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 non-profit organizations also sponsor clinical trials.
Where to find a clinical trial
The following websites offer more information on clinical trials and/or help in finding a clinical trial.
National Cancer Institute (NCI) clinical trials website
http://www.cancer.gov/clinicaltrials/
National Institutes of Health (NIH) clinical trials websites
http://www.cc.nih.gov/
http://www.clinicaltrials.gov/
BreastCancerTrials.org
http://www.breastcancertrials.org
CenterWatch clinical trials listing service
http://www.centerwatch.com/
Coalition of Cancer Cooperative Groups
http://www.cancertrialshelp.org/
ECancerTrials.com clinical trials matching and referral services
http://ecancertrials.com/
Updated 08/26/09
