Clinical Trials

During the course of your breast cancer treatment you may be asked if you would like to consider taking part in a clinical trial.

What is a clinical trial?

Clinical trials are studies involving patients, conducted in order to help find better ways to prevent, diagnose, or treat diseases. Clinical trials are research studies that involve patients to help find better treatments. When we think of treatments for breast cancer, we often think that only means surgery, but they can include drugs, radiotherapy, supportive care programs, complementary therapies or even exercise. In breast cancer, there are clinical trials for a range of treatments (including prevention).

Clinical trials are conducted under supervision by researchers so that the effects of the treatments being studied are properly monitored. Some trials compare new treatment options with current treatments, others look at different ways of using treatments or combining two or more existing treatments to see if they lead to improved benefits for patients. Clinical trials play an important role in a research process that can take years before new treatment options become part of standard breast cancer care. Most of the major advances in breast cancer treatment have occurred because the value of new treatments was first demonstrated in clinical trials. Two major advancements include breast conservation as a safe alternative to mastectomy, and more recently the use of sentinel node biopsy as an alternative to removing all the glands under the arm.

Why are there clinical trials?

Studies involving cancer patients try to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective. The major advances that have been made in breast cancer treatment were first tested in carefully conducted clinical trials. Each clinical trial must be approved by an ethics committee established by each hospital and health service. Ethics committees are regulated by the National Health and Medical Research Council (NHMRC), a federal government body. They are independent, meaning they are made up of scientists, doctors, lawyers, ministers of religion, and members of the general community and not members of the research team.

Who runs clinical trials?

Clinical trials are run by teams of researchers at universities, hospitals and private institutes and by drug companies. In Australia, many clinical trials for breast cancer are coordinated through the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG). The ANZBCTG involves more than 300 researchers in Australia and New Zealand. Jane O’Brien is a member of the ANZBCTG. For more on ANZBCTG and its current programmes see www.anzbctg.org

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:

Phase I trials: These first studies in people evaluate for example how a new drug should be given eg by mouth, injected into the blood, or injected into the muscle, how often, and what dose is safe. A phase I trial usually enrols only a small number of patients, sometimes as few as a dozen.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). The trial is considered a ‘double-blinded study’ if neither you nor your doctor knows which treatment you are receiving Phase III trials often enrol large numbers of people and may be conducted at many centres nationwide. In Australia, most clinical trials for breast cancer – especially those involving new drugs – are part of large-scale trials involving thousands of patients around the world.

In addition, after a treatment has been approved and is being marketed, the drug’s maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials.

What are the advantages and disadvantages of participating in a clinical trial?

The advantage of participating in a clinical trial is that you may receive newer treatments that are not yet available to the general public and may be more effective. By participating in a clinical trial you will also be helping other women who are diagnosed with cancer in the future.

The disadvantage of participating in a clinical trial is that the newer treatments may not be more effective than standard treatments and may have more side effects. Also, many clinical trials have a control group which means that you may not receive the newer form of treatment during your participation in a trial. You will not be able to choose whether you are in the group that receives the newer treatment or in the control group. However, you will always receive the best proven care.

Why have I never been approached about a clinical trial?

One reason why you may not have been told about a clinical trial is because there wasn’t a trial at the time of treatment that suited your particular type of breast cancer.

How do I decide whether to participate in a clinical trial?

If you are invited by your doctor to enter a clinical trial you need to weigh up the risks and benefits of this decision. The decision to participate in clinical trials can be difficult. Patients are often asked to make their decision about trials at a time when they are only just recovering from diagnosis and surgery. There is already so much to think about. The choice of whether or not to participate in a clinical trial is a very personal one, which is why it’s so important to be fully informed.

Many women decide to join a clinical trial because:

  • The treatment they will receive is at least the best available for their breast cancer
  • Current treatments are no longer working for them and clinical trials offer access to treatments under study and not widely available
  • Their health will be carefully checked by those running the trial
  • They want to be part of an effort to find better ways to treat breast cancer
  • They access free medication

Many women decide not to join a clinical trial because:

  • They want to receive the current standard treatment for their breast cancer
  • They wish to retain control of their treatment choice rather than being part of a trial in which
    treatment may be allocated

  • They feel there is still too little known about the risks and side effects of treatments under study
  • Their doctor is not involved in running a trial and they don’t want to change doctors
  • There is already enough to think about without having to consider a trial

You should be assured that refusal to take part in a trial will not compromise your treatment in anyway. You are also able to leave a clinical trial at any time without prejudice to your ongoing treatment.

Cancer Council Victoria has a useful website that allows you to search for clinical trials in Victoria that may be appropriate for you. Follow this link and click on the search for a clinical trial

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