Over the past 40 years, breast cancer treatment has greatly improved due to lessons learned through clinical trials.
Clinical trials test the safety and benefits of new treatments, diagnosis methods and screening tests.
People volunteer to take part in these research studies. Those who join clinical trials help further the knowledge base that helps improve breast cancer care.
Whether a new therapy or test becomes part of standard treatment for breast cancer depends largely on clinical trial results.
For example, clinical trials showed the benefit of hormone therapies and trastuzumab (Herceptin) and these drugs are now part of standard breast cancer treatment.
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 done at the same time in many sites across the country. These are called cooperative group clinical trials, and 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.
There are four main types of clinical trials for new breast cancer treatments:
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 trial.
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. 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 aren’t used in metastatic breast cancer clinical trials and aren’t commonly used in other cancer trials.
Most often in a breast cancer treatment clinical trial, you will get either the new treatment or the standard treatment. So, even if you don’t get the new drug (or other new therapy), your breast cancer will be treated the same as if you weren’t in the trial. Breast cancer trials never use a placebo instead of standard treatment.
Sometimes in a non-metastatic breast cancer trial, you may get the standard treatment plus a placebo rather than the standard treatment plus the new treatment (being studied). Your health care provider or the clinical research staff can tell you if there’s a placebo (in addition to the standard treatment) in the study.
Where you live may be a factor in choosing to join a clinical trial.
Some clinical trials are done in only one (or a few) medical centers. Others are done in many places across the country.
There may not be a clinical trial that’s right for you in your area.
The risks of a new treatment may not be fully understood, so there may be some unexpected side effects.
Testing limits these risks as much as possible. However, all the side effects of a new treatment are often not known until after long-term testing and follow-up.
The cost of a new treatment or test being studied is 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 now requires insurance companies to cover non-research, standard care costs related to a clinical trial (that aren’t covered by the trial itself) plus any standard treatment given.
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 don’t have any unexpected costs, such as out-of-network fees.
Clinical trials at the Clinical Center of the National Institutes of Health (NIH) in Bethesda, MD are free of charge to those who are eligible to join and willing to get treatment there. For more information on these studies, visit the NIH clinical center website or call 1-800-4CANCER.
All clinical trials have specific criteria for joining the study.
For example, each trial will have a list of medical conditions people must have (or not have) in order to join the study.
Learn more about eligibility criteria.
There are clinical trials for people who have completed breast cancer treatment.
These trials study topics such as the long-term effects of breast cancer treatments or the survival benefits of lifestyle behaviors (for example, diet and exercise).
Learn more about ways to get involved in breast cancer research.
Though most clinical trials study treatments, some focus on other areas of breast cancer, such as prevention and screening.
These studies often look for people who have never had breast cancer to take part in the study.
If you are newly diagnosed with breast cancer, consider joining a clinical trial before starting treatment.
For most people with early breast cancer, treatment doesn’t start right after diagnosis. So, there’s time to find a clinical trial that might meet your needs.
Once you’ve begun standard treatment for early breast cancer, it can be difficult to join a clinical trial.
If you have a breast cancer recurrence, 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 a clinical trial when your provider is considering changing treatments or before starting a new treatment.
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 may also be helpful in your decision-making process.
All clinical trials have guidelines (eligibility criteria) for who can join the study.
Criteria vary from study to study and may be based on:
Most clinical trials are designed for select groups of people, so it’s important to find a trial that fits your situation.
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 is the process of reviewing the risks, benefits and options for the study. It‘s 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:
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 can leave the trial at any time, for any reason.
Consenting and giving your written permission to join the study does not force you to stay in the study.
Before joining a clinical trial, talk with 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.
You may also record the discussion so you can review it later.
It’s a good idea to bring a list of questions and concerns. The following questions may be useful for your discussion.
(Adapted from American Cancer Society and National Cancer Institute materials [167-168]).
Most clinical trials are funded by the National Cancer Institute (NCI), a government agency.
NCI also sponsors groups that study the same cancer topic, such as the American College of Radiology Imaging Network. These groups include hospitals, universities and physicians who work together to study 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.
BreastCancerTrials.org in collaboration with Susan G. Komen® offers a custom matching service to help you find a clinical trial that fits your health needs.
For people diagnosed with metastatic breast cancer, BreastCancerTrials.org in collaboration with Komen offers a new web-based personalized clinical trial matching tool - the Metastatic Trial Search. This tool makes finding out about metastatic breast cancer clinical trial options easy and fast.
The following websites offer information on clinical trials and help in finding a clinical trial.
CenterWatch clinical trials listing servicewww.centerwatch.com/
Coalition of Cancer Cooperative Groups www.cancertrialshelp.org/
National Cancer Institute (NCI) clinical trials website www.cancer.gov/about-cancer/treatment/clinical-trials
National Institutes of Health (NIH) clinical trials websites www.cc.nih.gov/www.clinicaltrials.gov/
Clinical trials offer the chance to try new treatments that may be more effective than standard treatments.
Other types of studies, such as cohort and case-control studies, do not offer a possible treatment benefit. However, findings from such studies can still be helpful.
Cohort and case-control studies help increase our understanding about breast cancer in many ways. For example, they help us learn about risk factors and survivorship.
Learn more about different types of research studies.
SUSAN G. KOMEN® SUPPORT RESOURCES
*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.
Breast Cancer 101 - Clinical Trials
Breast Cancer Clinical Trial Information Helpline
Facts for Life: Clinical Trials
Questions to Ask Your Doctor about Clinical Trials
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