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20 May 2019


International Clinical Trials Day is a timely reminder of how far we have come in breast cancer research but importantly, why there is still more work to do.

May 20 each year marks the anniversary of the day James Lind began the world’s first clinical trial to investigate the prevention and treatment of scurvy in 1747.

At the time, HMS Salisbury of the British Royal Navy was patrolling the English Channel and scurvy was thought to have killed more British seamen than French and Spanish arms.

James Lind was a surgeon mate on board the ship and had a hunch that the putrefaction of the body could be cured through the introduction of acids.

Lind’s pioneering randomised controlled trial consisted of just 12 men and two men were allocated to each of the six different treatments – cider, diluted sulphuric acid, vinegar, sea water, two oranges and one lemon, and a paste made up of garlic, mustard seed, dried radish root and gum myrrh.

According to Lind’s report, the men who took the citrus fruits experienced “the most sudden and good visible effects” on the trial.

While clinical trials started as very humble research more than 270 years ago, they have grown to become one of the most important scientific research endeavours that have changed clinical practice and the treatments available to patients today.

A clinical trial asks a scientific question and aims to identify if a new treatment is better than the current standard of care.

All of the major milestones in controlling breast cancer, for example, have come through clinical trials, and women have also benefited from improved screening and early detection.

During the last two decades, breast cancer mortality has fallen by more than 30 per cent and more women than ever before are surviving their diagnoses.

The research program of Breast Cancer Trials has played a significant role in these breakthroughs and has meant Australian women have had access to new treatments sooner.

Breast Cancer Trials (BCT) is Australia’s largest, independent, oncology clinical trials research group and for more than 40 years, BCT has been conducting multicentre national and international clinical trials, bringing together almost 800 researchers across more than 100 institutions throughout Australia and New Zealand.

Take for example the HERA clinical trial, which was ground-breaking research for women with HER2-positive breast cancer – a more aggressive form of the disease affecting approximately 20 to 30 per cent of women with breast cancer.

HERA found that the administration of trastuzumab (Herceptin) following standard chemotherapy reduces the risk of the disease returning for these women by 46 per cent.

This trial enrolled 5,000 women from 39 countries worldwide, including 110 women from Australia and New Zealand.

Results from a joint interim analysis of more than 3,000 patients from two North American trials provided similar and equally remarkable results for trastuzumab in early-stage HER2-positive breast cancer. This data, at a median follow-up of two years, showed that trastuzumab in combination with a specific chemotherapy regimen provided a 52 per cent reduction in risk of cancer coming back as well as a 33 per cent reduction in risk of death.

The Prevention of Early Menopause Study (POEMS) clinical trial offered a new treatment option for young women with breast cancer, to better preserve their fertility during cancer treatment.

Chemotherapy is usually given to women with breast cancer to destroy any remaining cancer cells after surgery and to prevent these cells from growing and spreading to other parts of the body. One in four breast cancer patients are premenopausal and, unfortunately, a common long-term side effect of this treatment is early menopause. In addition to avoiding the potential long-term medical problems resulting from early menopause (such as osteoporosis and heart disease), many young women also wish to avoid infertility which may result from treatment.

The POEMS clinical trial found that women who received the drug goserelin were less likely to be in menopause two years after their cancer treatment and were twice as likely to have a normal pregnancy after their cancer treatment.

A total of 256 women participated in this study worldwide, including 58 women from Australia and New Zealand.

There have also been other clinical trials which have looked at how we can prevent breast cancer in women at higher risk of the disease.

The IBIS-I clinical trial for example looked at whether the hormone therapy drug tamoxifen could reduce the risk of breast cancer developing in women aged 35 to 70, with a family history of the disease.

Initial IBIS-I results released in 2002 demonstrated that tamoxifen reduced the risk of hormone receptor positive breast cancer developing by about one third in pre and post-menopausal women at increased risk of the disease.

Long-term follow up of IBIS-I released in 2006, found that tamoxifen reduced the risk of hormone receptor positive breast cancer by 34 per cent in women at increased risk and that the benefit continues for at least several years even after treatment with the drug has stopped. This accounts for two thirds of all breast cancers.

In 2014, new extended analysis of tamoxifen showed that the preventative effect of the drug continues for 20 years.

More than 7,100 patients worldwide participated in the IBIS-I clinical trial, including 2,674 from Australia and New Zealand.

While these are fantastic results produced by clinical trials, our work is a long way from being complete.

This year, more than 19,500 people will be diagnosed with breast cancer, which equates to 53 people every day and recent statistics from the Australian Institute of Health and Welfare show that breast cancer will likely become the most diagnosed cancer of all cancers in 2019.

Clinical trials have improved the treatment of breast cancer, led to changes in the way breast cancer is managed and saved millions of lives through research collaboration.

It is only through clinical trials research that we will find new and better treatments and prevention strategies for every person at risk or diagnosed with breast cancer, so that they can get on with living and loving their lives.



Published: 20 May 2019