Clinical trials

Clinical trials are scientific research studies used to discover new or better cancer treatments and care.

Most of the major treatment advances for breast cancer are based on results from clinical trials conducted with people in Australia and overseas.

Some clinical trials test drugs, while others test treatments, such as radiotherapy and surgery. Clinical trials can also investigate the emotional and physical side effects of breast cancer and its treatment and explore ways of improving the quality of life of people affected by cancer.

Clinical trials are run through public and private hospitals. When the results of a trial show that a new treatment is more effective than an old treatment, the new one becomes the standard treatment. New treatments or tests must be proven to be safe and effective through clinical trials before they become standard treatment.

However it can take some time for the trial data to show the effectiveness of the drug in comparison to current standard therapy.

Treatment advances through clinical trials

Treatment advances that have been tested through clinical trials include:

• That breast conserving surgery followed by radiotherapy can be a safe alternative to mastectomy for many women diagnosed with early breast cancer.
• The introduction of trastuzumab (Herceptin) for treatment for HER2-positive breast cancer.
• That adding a CDK inhibitor, such as ribociclib and palbociclb, to hormone-blocking therapy can slow down the progression of hormone positive, HER2-negative metastatic breast cancer.
• That extending aromatase inhibitor treatment for more than five years can provide further protection against a breast cancer recurrence for women with hormone positive early breast cancer.
• That hypofractionated radiotherapy (i.e. a shorter, more intense course of radiotherapy) may be as effective as conventional radiotherapy for some women aged 50 and over who have cancer at an early stage and who have had breast conserving surgery with clear surgical margins.

About the ‘control group’

A key concern some people have when thinking about whether to participate in a clinical trial is whether they will receive substandard treatment, or even no treatment, if they are allocated to the control group of the clinical trial.

The control group is the group that provides a comparison by not receiving the new treatment being tested in the trial. However, all clinical trials are very carefully regulated; if you are allocated to the control group, you will receive the current standard treatment (i.e. the treatment you would have received if you were not participating in the clinical trial).

Levels of participation

While clinical trials are vital in improving the treatment and health outcomes of Australians affected by breast cancer, not all Australians have equal access to clinical trials. Participation in cancer clinical trials in Australia is generally low.

Approximately 5% of Australians diagnosed with cancer currently participate in clinical trials. 

People in rural or remote parts of Australia can have difficulty participating if clinical trials are only run in treatment centres located in major cities. Research indicates that people from culturally and linguistically diverse backgrounds may experience barriers to participation, for example language barriers. 

People diagnosed with breast cancer who have other health conditions (i.e. comorbidities) may not be eligible to participate in some clinical trials due to concerns about safety – for example, there may be a concern about how a clinical trial may impact people’s other health conditions and about the impact of potential side effects from the new treatment being studied. Men affected by breast cancer may also be excluded from participating in some clinical trials due to eligibility criteria.

BCNA’s 2017 Member Survey also found that a significant proportion of Australians with metastatic disease (45%) felt like they have not had opportunities to talk about clinical trials that may be of benefit to them.

How trials are run

Some clinical trials are run by researchers at universities, hospitals or private institutions and other are run by pharmaceutical companies.

In Australia, many clinical trials for breast cancer are run through Breast Cancer Trials Australia (BCT), a group of over 800 researchers and clinicians in Australia and New Zealand.

More than 14,000 people affected by breast cancer have participated in their clinical trial program. Find out more about Breast Cancer Trials Australia.

How to get involved

If you have been diagnosed with breast cancer and are interested in finding out about clinical trials that may be open to you, you can ask your doctor if they know of a trial that might suit you.

Your doctor may also discuss clinical trials that may suit you during your treatment discussions.

You can also search for trials on the Breast Cancer Trials Australia website or the Australian Government’s Australian Clinical Trials website and talk to your doctor about whether particular clinical trials may be relevant and appropriate for you.

Benefits of participating

Possible advantages of participating in a clinical trial:

• You may get access to a new type of treatment.
• You will get an excellent standard of care and be closely monitored by leading doctors, research nurses and other experts.
• Research shows that patients treated in clinical trials usually fare better than those who are not involved.
• You will be helping researchers develop new treatments for breast cancer that will help people in the future.

There is absolutely no obligation to participate in a clinical trial. If you do chose to take part, you are free to leave the trial at any time.

Possible concerns of participating

The decision about whether or not to participate in a clinical trial is a personal one. Concerns may include:

• There may be side effects which you find difficult to manage. If this is the case, you can choose to leave the trial.
• You may need to set aside extra time for appointments.
• There may be out-of-pocket costs or you might need to travel further for your treatment if your usual doctor is not participating in the trial.

Your doctor will be able to answer questions you may have about a clinical trial, if you are considering whether or not to participate in one.

What participation involves

To take part in a clinical trial, you first need to be eligible.

Depending on the trial, criteria such as your age, type of cancer, stage of cancer, previous treatment and any other medical issues will be taken into account. Using certain complementary or alternative medicines may mean you cannot participate in some clinical trials.

The reason eligibility criteria for clinical trials are quite specific is that the researchers are trying to establish that the results from the study are due to treatment, test or procedure being studied and not due to other factors.

If you are eligible for a suitable trial, your doctor will give you written information to read to help you make your decision. The written information will outline:

• what treatment is being studied
• all foreseeable benefits and risks (including side effects)
  Full details of what is required of patients, such as appointments for treatments or tests
• your rights – the most important of your rights is the right to opt out of the trial at any time for whatever reason, without future medical care being affected