ANZBCTG STUDY IS FINALIST IN CLINICAL TRIAL OF THE YEAR AWARDS

The SOFT clinical trial, which produced practice changing results in the treatment of breast cancer in young women, was recognised as a finalist in the inaugural Australian Clinical Trials Alliance’s (ACTA) Clinical Trial of the Year Awards. ANZBCTG is one of 60 Clinical Trials research groups in Australia affiliated with ACTA. The Award Ceremony was held at Monash University in Melbourne on International Clinical Trials Day and attended by the Federal Health Minister, Ms Sussan Ley, who announced the winner.

The Awards recognise and celebrate the outstanding achievements of members who have advanced clinical practice through collaborative, multicentre investigator-driven clinical trials. The SOFT clinical trial was one of five finalists in the awards and was conducted in Australia and New Zealand by the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG).

More than 3,000 women were enrolled in the clinical trial worldwide, including 240 women from Australia and New Zealand. Associate Professor Prue Francis is the International Co-Chair of the SOFT clinical trial and attended the awards ceremony in Melbourne to accept the finalist award. A/Prof Francis presented the study results at the San Antonio Breast Cancer Symposium in Texas, USA in December 2014, and was the lead author of the publication in the New England Journal of Medicine in 2015.

The SOFT clinical trial found that treatment with tamoxifen plus ovarian function suppression did not significantly benefit all premenopausal women. However the addition of ovarian suppression to tamoxifen reduced the relative risk of developing invasive breast cancer recurrence by 22% in women who did not transition into menopause after receiving chemotherapy, when compared to treatment with tamoxifen alone. A secondary analysis showed that further benefit could be gained by treating these women with an aromatase inhibitor exemestane plus ovarian suppression, which reduced their relative risk by 35%, compared to tamoxifen alone, resulting in 7 to 8 fewer women out of 100 having a breast cancer recurrence within 5 years.

The winner of the Clinical Trial of the Year Award was the PPROMT clinical trial. This was a ground-breaking ten-year, Australian-led international trial of more than 1,800 pregnant women in 11 countries, led by Professor Jonathan Morris from the Interdisciplinary Maternal Perinatal Australasian Collaborative Trials network and Sydney’s Kolling Institute. The trial’s aim was to improve the outcome in pregnancies when women rupture their membranes early, which occurs in 40 per cent of pre-term deliveries.

As a result of the trial, practice at the Monash Medical Centre in Melbourne has changed to no longer recommend delivery for women at and beyond 34 weeks gestation shortly after rupture occurs, rather to monitor the women in the hope of achieving a longer pregnancy.

The ANZBCTG’s research program involves multicentre clinical trials, with 87 institutions and over 700 researchers throughout Australia and New Zealand. More than 14,000 women have participated in ANZBCTG breast cancer clinical trials. The fundraising department of the ANZBCTG is the Breast Cancer Institute of Australia (BCIA).

For more information about the ANZBCTG, visit the website www.anzbctg.org. Media contact: Anna Fitzgerald, ANZBCTG Communications Manager Phone: 02 4925 5255 or 0400 304 224 or Email: anna.fitzgerald@anzbctg.org