CLINICAL TRIALS RESEARCH
Clinical trials are an important aspect of developing new
and improved health care initiatives. Breast cancer clinical trials are designed to
answer scientific questions, which may result in
the identification of new and improved treatment
options and preventative therapies.
Clinical trials are necessary to find out if new treatments
are more effective than those currently accepted as
the best available standard treatment.
All of the major milestones in controlling breast
cancer worldwide have come through clinical trials.
- Chemotherapy and hormone treatment prevents
recurrence and saves lives;
- Mammograms save lives through earlier detection;
- Removing just the cancer and preserving the breast is a safe and
effective treatment for most women;
- Breast cancer can be prevented in some women at increased risk;
- Treatments targeted to the specific type of breast cancer can improve
All new treatments and procedures must be scientifically proven through
clinical trials research before they can be adopted as standard treatment
for women diagnosed with breast cancer.
People take part in clinical trials for many reasons including:
- They may be able to access a new treatment before it
is routinely available as standard treatment for all breast
- The treatments offered on a clinical trial include the
best current standard treatment, compared with a new
treatment which earlier research shows may be better;
- Participating in a clinical trial helps to advance
- Many clinical trial participants are motivated to take part because the
results of current clinical trials may help improve treatments and outcomes
for future women diagnosed with breast cancer or who are at risk.
Clinical trial participants may be monitored more closely than patients who
receive standard treatment and their treatment is rigorously documented.
There are usually questionnaires to complete regarding the participant’s
feelings or reactions to the treatment. This careful follow up means that
the outcomes of the clinical trial are the result of accurate and detailed
information which is then published in peer reviewed scientific journals.
The guiding document for the conduct of a clinical trial
is called a protocol. Clinical trial protocols are written
by experienced clinicians and a team of experts in
breast cancer treatment, translational research and
trials coordination. All clinical trials conducted by
the ANZBCTG are monitored by the ANZBCTG
Scientific Advisory Committee.
The clinical trial protocol outlines the reason for doing
the study, who may participate, the treatments and tests
involved, when these will be done and why. The protocol must
be approved by an independent panel of scientists, medical professionals
and consumers, called an ethics committee. The progress of the clinical
trial and the safety of clinical trial participants is carefully reviewed and
monitored by an Independent Data and Safety Monitoring Committee and
by the ethics committee responsible for approving the clinical trial.
Before joining a clinical trial, potential participants must understand why
the clinical trial is being conducted, the potential risks and benefits and
what their involvement would include. The decision to participate is made
on the basis of information provided to the patient by her treating doctor.
Written information about the clinical trial will also be provided.
Both the doctor and the potential participant must be satisfied that all
information about the clinical trial is understood and a statement to this
effect is signed by both parties. This process is called “obtaining informed
consent to participate in a clinical trial”.
There are many types of clinical trials for the prevention and treatment of
breast cancer, and studies which aim to improve a patient’s quality of life.
Prevention clinical trials are designed to test new strategies to prevent
breast cancer for women who have never had the disease but who are
at high risk.
Treatment clinical trials are designed to find out which treatments are the
most effective and to test new treatments to see if they are better at
improving outcomes for patients compared to the current standard
Quality of life assessments pay special attention to the breast cancer
patient’s feelings about the impact and side effects of treatment. The aim
of these assessments is to look for ways to improve the overall experience
of the patients who receive these treatments in the future. The ANZBCTG
has pioneered the measurement of quality of life in patients and carried
out this research for more than 30 years.
If you would like to participate in a breast cancer clinical trial you should
discuss this with your cancer specialist.
A list of ANZBCTG clinical trials that are open for
participant entry is available at www.anzbctg.org
Information about breast cancer clinical trials
can also be found on the Australian New Zealand
Clinical Trials Registry website at www.anzctr.org.au
A Decision Aid tool, which is designed to help people considering joining a clinical trial, is available on the Cancer Australia
For more information on ANZBCTG Clinical Trials currently open for entry, please