Clinical trials for breast cancer

Researchers and doctors are always looking for better ways to treat cancer. To make scientific advances, clinical studies are developed, and new drugs and approaches are tested on volunteer patients. All drugs given in Canada must be rigorously tested with this type of study before they can be approved by Health Canada.

A clinical study seeks to find out if a new treatment is safe and effective and better than the treatments in use. Various elements can be studied:

• New drugs
• Different combinations of existing treatments
• New approaches or methods
• New methods to relieve disease symptoms and treatment-related side effects
• Cancer prevention, detection or early screening methods
• Diagnostic methods
• Effect of complementary care

Patients may decide to join in a clinical study for a number of reasons:

• They are proving to be a source of hope when other treatments are not working,
• They are also sometimes used to improve current treatments,
• Participating in a clinical study is one way to contribute to advancing research.

The main benefits of participating are:

• Having access to the most innovative care available;
• Benefit from new diagnostic tests, treatment algorithms and close medical follow-up;
• Contributing to the advancement of knowledge about breast cancer and its treatment for future generations of patients.

When you participate in a clinical study, you are among the first patients to receive a treatment, before it is available to everyone. You should be aware that a clinical study involves some risk. Side effects may occur, or the treatment may not work. It is important to discuss the pros and cons of participating in a clinical study with your care team. They can advise you in making this decision.

Clinical studies follow very strict ethical procedures to protect participants’ health, safety and privacy. Clinical studies are designed to minimize risks and optimize possible benefits. They follow very strict scientific and ethical guidelines that are reviewed by an ethics committee.

Your decision to participate in a clinical study must be an informed one. Before joining in a clinical study, you will be given all the details and asked to sign a consent form stating that the study has been fully explained to you and that you understand the implications of your participation. Informed consent ensures that:

• The options have been fully described and the patient understands the differences between standard and experimental treatment
• The risks inherent to the study have been explained
• The study procedure has been explained in detail (i.e., the number of visits, the schedule and the tests required)

You may get the placebo

It is important to know that in a clinical study you may not actually receive the experimental treatment. To find out if the new drug is effective, it must be compared to either the standard treatment or a placebo. So as not to bias the results, participants do not know which they receive. Studies are often randomized. This means participants are randomly assigned to one of the two groups.

Protective measures

• There is a list of eligibility criteria to ensure that the study is safe.
• You have the right to withdraw from the study at any time for medical or personal reasons.
• During the clinical study, you will be closely monitored by experts, who will detect any potential problem and be ready to act. You should discuss any concerns, problems or changes with your care team.

Bringing a new drug to market takes many years and involves five main steps.

During the preclinical phase, concept analyses are conducted in the laboratory, mainly with in vitro or animal tests.

During Phase 0, very small doses of a new drug are given to test its effect. This involves a very small group of people, who are usually healthy.

During Phase I, the safety of the new drug is assessed to determine the dose to be used and the method and frequency of its administration. It also aims to find out the drug’s effect on the body and its side effects. This phase involves 15 to 30 patients, generally those whose condition isn’t improving with standard treatment and patients with all types of cancer.

Phase II evaluates whether the drug is effective and safe for a specific type of cancer, depending on the dose and means of administration identified during the study’s Phase I. It involves fewer than 100 patients for whom standard treatment is not effective.

In the study’s Phase III, the new drug is evaluated in further depth by comparing its efficacy to the best standard treatment in use. This phase is conducted on between one hundred and several thousand subjects, often in several centres or hospitals. Patients in Phase III studies may not have received other treatments beforehand, since data from the previous studies show that the drug has some effectiveness.

Finally, to assess the long-term benefits and risks of the drug, a Phase IV is conducted with study subjects who already took part in Phase III. This last phase is conducted once the drug has been approved.

After all these study phases are completed, their detailed results are sent to Health Canada for careful review. If the results are conclusive, Health Canada approves the drug for clinical use. This whole process can take about 10 years.

List of clinical studies

Are you interested in taking part in a clinical study? You can visit the following sites to learn more about the clinical studies currently underway. Talk to your doctor!

(Clinical trials conducted in Canada, the United States and around the world)