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Breast Cancer Clinical Trials

Untitled Document

What Is a Clinical Trial?

New treatments for any condition or disease, including breast cancer, have to go through testing and government approval before they are made available to patients. These clinical trials are necessary to make sure new treatments (such as drugs) work the way they are supposed to, and are safe for patients. Clinical trials take place after researchers have demonstrated that they have conducted every other test possible to make sure the treatment has promise and is safe. The final step is to prove it works in humans so that it can be used in health care settings and/or by patients at home.

↓ How to find and join a trial

↓ Types of trials

↓ The different ways trials can be designed

↓ Trials

↓ What are the risks?

↓ What are the benefits?

↓ Should/Can I participate in a trial?

↓ Questions to ask

↓ More information on clinical trials

How to Find and Join a Trial

Current CBCF-funded trials

You can also search for breast cancer trials on the Canadian Cancer Clinical Trials Network (3CTN) site, where you can consult a list of trials or use a search form to find one. The site provides a link to a helpful search guide that explains the process. You can click on the trial number to find out more information, including the contact information for the person who is recruiting patients for the trial.

Health Canada also provides a search site for all clinical trials in Canada. If you are interested in learning more about a trial found on this site, but cannot find information about the recruiter, try searching for the trial sponsor online, as they may have the contact information of the  trial recruiter or coordinator. If you find a trial on this site which does not have information available on another site, such as ours or 3CTN, Health Canada suggests you search for the trial sponsor online to get the information of a contact such as a trial recruiter or coordinator.

If you have heard of a trial that you think you could be eligible for, record as much information as you can about it - such as the trial number and sponsor, which could help you find the trial through a search site like the ones listed above. You may need information about your diagnosis (e.g. stage) that can help you identify trials you could join. Once you have identified a trial you are interested in joining, you can contact the trial recruiter, when you will have the opportunity to ask questions before you commit to joining.

Types of Trials

Several aspects of cancer may be explored in a clinical trial. For breast cancer, these might include:

  • Prevention trials to study different approaches to reducing one’s risk of breast cancer, such as through a specific dietary change.

  • Screening trials which look at how to improve detection of cancer, for example by comparing the clarity of imaging in two different mammography technologies.

  • Diagnostic trials to determine the best ways to identify cancers accurately, for example a blood test that could help identify a specific breast cancer subtype.

  • Treatment trials - the most common type of clinical trial - to test new drugs or therapies, explore new combinations of treatments, study how to reduce side effects, etc.

  • Quality of Life trials to explore how to make the experience of disease and its treatment have a lighter impact on a person’s life – through, for example, reducing symptoms, improving pain control, making the experience of treatment and recovery less disruptive to a person’s life.

The Different Ways Trials Can Be Designed

When a researcher decides to carry out a clinical trial for cancer, there are many different possible structures for the trial. These include:

  • Randomized controlled trials (RCTs), considered the gold standard of clinical trials. In these trials, patients are randomly assigned to either a control treatment (the standard treatment cancer patients would receive) or an experimental treatment (the new treatment being tested). Random assignment ensures that each patient has an equal opportunity of being included in either group.

  • Blind trials which require that the patient is kept unaware throughout the trial of whether they are receiving the control treatment or the new treatment. Double-blind trials require that neither the researchers nor the patients know which treatment they are receiving. Research has shown that patients’ and doctors’ expectations can bias their reports of a treatment’s effectiveness, or the severity of its side effects, so blinding helps prevent this bias from affecting the results.

  • Placebo-controlled studies which test an experimental treatment (the new treatment being tested) against a placebo (a control treatment with no known medical effectiveness). Placebos are never used in the place of effective cancer treatments. Blind and double-blind trials are often used so that researchers and patients remain unaware of which patients receive the placebo vs. the new treatment. Placebos help to ensure that any perceived effect of the experimental treatment is actually due to the treatment, rather than to beliefs or expectations related to the treatment’s effectiveness.

Phases of Trials

Phase 0 

Phase 0 trials are not always part of the trial process, but can be conducted to test things like how a small dose of a drug affects a small sample of people. Usually, participants in Phase 0 trials have advanced disease for which no known treatment is available.

Phase I 

Phase I trials are mainly a test of the treatment’s safety and are conducted on a small number of people. 

These trials ask:
  • Are there any side effects?
  • What dosage or amount is safe to use?

Phase II 

Phase II trials extend testing to a larger group of patients (usually over 100) to test how well the treatment works. 

These trials ask:
  • How well does it work for the specific condition/disease?
  • What is the best dose or amount?
  • Are there any further safety issues?

Phase III 

Phase III trials involve an even larger group of patients (usually over 1000) to collect more information.

These trials ask:
 • Are the findings from the Phase II trial confirmed by this trial?
 • What side effects are there?
 • How well does it work compared to other treatments for the same condition/disease?
 • What do we need to tell doctors and patients about how to use the treatment safely?

Phase IV 

Phase IV trials happen after a treatment is approved and available for use. Because of this, they potentially involve the whole population of people for whom the treatment is appropriate, and gather information from the doctors whose patients are using the treatment (rather than from a team of researchers in a controlled environment).

These trials ask:
  What is the best way to use the treatment? (e.g. frequency and doses for different people)
  • What are the long-term effects of the treatment, both good and bad?


What Are The Risks?

  • The treatment being tested may not work for every participant in the trial – including you.

  • The treatment may not necessarily be better than the treatment you have already tried. 

  • Because the treatment is still being tested, there could be unexpected side effects. 

  • In blinded randomized controlled trials you won’t be able to control whether you are receiving your existing cancer treatment or the new experimental one; so, there is a chance the treatment you did not receive would have been more effective for you.

  • There may be extra tests or questionnaires involved, which could be inconvenient at times.

What Are The Benefits?

  • The greatest potential benefit is that you may get access to a promising new treatment, which could help fight your disease, improve your quality of life, or bring other benefits.

  • You will get access to more health information and health monitoring because you will be required to speak to the expert research team frequently.

  • You will be helping researchers advance knowledge about breast cancer, which will benefit countless others facing your diagnosis in future.

Should I Participate In a Trial?

People who participate in clinical trials may enter the trial to see if experimental treatments may work better for them than conventional ones, or they may be willing to consider additional treatments for things like symptom control. If you have a form of breast cancer that has developed drug resistance, for example, you can look for a trial that is targeting your specific form of cancer, or is testing a strategy to combat drug resistance. You should talk to your doctor when making these decisions, as she or he can help answer many of your questions.

Questions to Ask

There are many questions you can ask about a clinical trial before agreeing to join. Some of these, your doctor may be able to answer; others, you may have to ask the recruiter for the trial. 

These might include:

  • What kind of trial is it?
    (see information above on trial types, designs, and phases)

  • What kinds of tests and experimental treatments are involved, and how are they different from standard care?

  • How might this trial affect my daily life?

  • How long will it take until they have some results, and will they share them with me?

You can print this list of questions to discuss with your doctor and decide which ones you’d like to bring to the trial recruiter.

More information on clinical trials from other organizations

Canadian Cancer Clinical Trials Network (3CTN)

Canadian Cancer Society

Kidney Cancer Canada

Prostate Cancer Canada

NCIC Clinical Trials Group – Breast Disease Site

Canadian Stem Cell Foundation

Health Canada Clinical Trial search site

Organizations outside of Canada (some details will be different)


Susan G. Komen for the Cure

Cancer Research UK

MacMillan Cancer Support

Roche Pharmaceuticals and Diagnostics (video