Australian New Zealand Breast Cancer Trials Group
Breast Cancer Trials has information about current trials.
Australian and New Zealand Clinical Trials Registry
Searchable register of clinical trials available in Australia.
What happens in a clinical trial?
In a clinical trial, there are usually two groups of patients:
- those who receive the newer treatment (the intervention group)
- those who receive standard treatment (the control group).
Standard treatment is the currently recommended treatment. In some cases, standard treatment may be no treatment. This is called best-supportive care.
Two groups of patients are needed, to see whether the newer treatment is better than standard treatment. Women who take part in a clinical trial cannot choose whether to have the newer treatment or standard treatment.
There are no additional costs for people who join a clinical trial.
What are the phases of a clinical trial?
The ‘phase’ of a clinical trial refers to how much is known about the new treatment/test.
- A Phase I trial is the first time a treatment is tested in humans. Phase I trials usually involve a small number of healthy volunteers or patients and a range of doses to test how the body responds to the treatment and to look for side effects.
- A Phase II trial tests the effects of a drug in people with a particular disease. These trials usually involve small numbers of patients and are used to work out the correct dose of the treatment and how effective it is in the short term.
- A Phase III trial compares the effect of a new treatment with the current standard treatment and usually involves large numbers of patients in several countries.
- A Phase IV trial is a trial or study of a drug that is already approved. Phase IV studies check how well a treatment works over a longer period of time and monitor long-term side effects.
Advantages and disadvantages of being in a clinical trial
Advantages of being in a clinical trial include:
- people on a clinical trial may receive a newer treatment that is not yet available to the general public
- the newer treatment may be more effective than standard treatments
- the progress of treatment will be monitored closely
- people who join clinical trials will also be helping other women who are diagnosed with breast cancer in the future.
Disadvantages of being in a clinical trial include:
- it’s not possible to choose which treatment to have
- the newer treatment might not be more effective than standard treatments
- the newer treatment might have more or different side effects compared with standard treatments
- more tests may be needed during and after treatment than with standard treatments
- it may be necessary to fill in more forms and surveys than with standard treatments
- people in the control group will not receive the newer treatment.
Questions to ask about clinical trials
Listed below are some questions that may be helpful when talking about clinical trials:
- What’s the purpose of the trial?
- What treatments or tests does the trial involve?
- What treatments or tests will I have if I do not join the trial?
- What are the advantages and disadvantages of joining the trial?
- What are the possible side effects of the treatment or tests being studied in the trial?
- What are the possible side effects of the treatments or tests I will have if I do not join the trial?
- What follow-up tests will I have if I join the trial?
- Have the treatments been used before to treat other types of breast cancer?
- Have the treatments been used before to treat other cancers?
- Can I leave the trial at any time?
- Are there any costs involved if I join the trial?
Where to find more information on clinical trials
Several different organisations have information available on their websites about clinical trials for breast cancer in Australia.