Clinical Trials

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 as well as new combinations (or new doses) of standard treatments. They can also study other parts of care including risk reduction, diagnosis and screening.

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.

Read the 2018 Research Fast Facts on Clinical Trials here.

The Importance of Clinical Trials

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.

Phases of Clinical Trials

There are 4 main phases of clinical trials for 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 25-100 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).Phase 3 trials study the best way to give the new treatment to get the most benefit and whether it’s better than the current standard treatment.They 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 don’t get to choose which treatment they will get. This ensures the study results reflect the true benefits and risks of the new treatment.
  • 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). Not all clinical trials fall neatly into 1 category. Some trials may be a combination of 2 categories, such as a phase 1/2 or phase 2/3 trial.
  • Phase 0 (early stage 1) trials are different from other phases of clinical trials because they have no treatment goals and they are not part of the FDA approval process [213]. Phase 0 trials can give information on whether a drug does what it’s expected to do (based on cell and/or animal data) [213-214]. For example, the trial may look at whether the drug can reach the cancer and how cancer cells in people respond to the drug [213-214]. They study a very small dose of a drug in a small number of people (usually fewer than 15 people) and last less than a week [213-215]. The dose of the drug is so small there is no possible treatment benefit [214-215]. However, this also means the chance of side effects is low [214]. Although not common, phase 0 trials can be an important first step in human studies of a new drug treatment.

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 (except for phase 0 trials).

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 non-metastatic breast 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.

Possible Draw Backs

ELIGIBILITY

All clinical trials have specific criteria for joining the study, so you may not be eligible for a trial. Or, there may not be a clinical trial currently recruiting participants that’s right for you.

Learn more about eligibility for clinical trials.

LOCATIONS

Where you live may be a factor in choosing to join a clinical trial.

Some clinical trials are done in only 1 (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, so you may have to travel if you want to participate.

Learn about programs that offer transportation and lodging assistance during treatment.

SIDE EFFECTS

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.

FINANCIAL ISSUES

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. However, there may be additional costs if the trial is in a different medical center. For example, you may have extra costs related to travel or parking.

The Affordable Care Act 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.

Learn about programs that offer transportation and lodging assistance during treatment.

Learn about financial assistance.

Komen Treatment Assistance Program
Susan G. Komen® partners with CancerCare® to offer the Komen Treatment Assistance Program which bridges the gap for underserved individuals who are actively undergoing breast cancer treatment.

With this program, we aim to help those who are facing financial challenges by providing the following to low-income, underinsured or uninsured women across the country: an assessment by an oncology social worker, limited financial assistance, breast cancer education, psychosocial support and information about local resources.

Funding helps women of any age who have been diagnosed with breast cancer, at any stage of the disease. Financial assistance is granted to women who meet pre-determined eligibility criteria. To learn more about this program and other helpful resources, call the Komen Breast Care Helpline at 1-877 GO KOMEN (1-877-465-6636).

 

Who can Join a Clinical Trial?

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) to join the study.

Clinical trials aren’t just for people who are undergoing cancer treatment. There are also clinical trials for people who have finished treatment and for those who have never had breast cancer.

Learn more about eligibility criteria.

PEOPLE WHO HAVE FINISHED TREATMENT

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.

PEOPLE WHO HAVE NEVER HAD BREAST CANCER

Some clinical trials focus on non-treatment 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.

Taking Part in a Trial

WHEN TO CONSIDER JOINING A TRIAL

If you’re 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’re diagnosed with metastatic breast cancer, consider joining a clinical trial when your provider is considering changing treatments or before starting a new treatment.

Talking with your Health Care Provider

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.

Eligibility 

All clinical trials have guidelines (eligibility criteria) for who can join the study.

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’s 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‘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:

  • Reason/rationale for the study
  • Study design
  • Treatment regimen (what drugs or other therapies will be used)
  • 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, 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.  

Questions for the Research Team

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.

  • Why is this study being done?
  • Who is sponsoring this study?
  • Can I join? How long do I have to decide about joining?
  • What are the potential risks and benefits of joining this clinical 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 will have?
  • Will I get a placebo?
  • What tests or treatments are involved?
  • How do the tests and treatments in this study compare to those in standard care?
  • How often do I need to come in for treatment and testing? What kinds of tests will be done?
  • How will you know if the treatment is working?
  • 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?
  • Will costs such as parking be covered?
  • Where is this study being done? Do I have to travel to participate? Should someone come with me?
  • 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 study ends?
  • 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 enrolled in the study that I can talk with?
  • How will I be told about the results of the study?
  • How will my personal information be protected in this study?
  • Who can I contact if I have more questions during or after the trial?
  • Are there other clinical trials I should consider that might offer more benefit for me?

(Adapted from National Cancer Institute materials [180]).

It may be helpful to download and print Susan G. Komen®‘s Questions to Ask Your Doctor card on clinical trials and take it with you to your next doctor appointment. There’s plenty of space to write down the answers to these questions, which you can refer back to later.

You can also download other Questions to Ask Your Doctor cards on many different breast cancer topics.

Who Sponsors Clinical Trials?

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.

Where to Find 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 needs.

Susan G. Komen® Breast Cancer Clinical Trial Information Helpline

If you or a loved one needs information or resources about clinical trials, call our Clinical Trial Information Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email clinicaltrialinfo@komen.org.

The Helpline offers breast cancer clinical trial education and support, such as:

  • Knowing when to consider a trial
  • How to find a trial
  • How to decide which trial is best
  • What to expect during a trial
  • Information about clinical trial resources

For people diagnosed with metastatic breast cancer, BreastCancerTrials.org in collaboration with Komen offers a web-based personalized clinical trial matching tool – the Metastatic Trial Search. This tool makes finding metastatic breast cancer clinical trial options easy and fast.

Metastatic Trial Research Tool

Find a Clinical Trial

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


www.breastcancertrials.org

CenterWatch clinical trials listing service
www.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/