While Australian patients have participated in breast cancer clinical trials for decades, there have been few trials testing neoadjuvant therapy. Commencing in 2000, the Cancer Council Victoria sponsored an investigator initiated single-arm phase 2 neoadjuvant breast cancer trial testing anthracycline-taxane chemotherapy with growth factor support, in locally advanced breast cancers, unselected by phenotype.
The Australia and New Breast Cancer Trials Group (ANZBCTG) conducted their first multi-centre neoadjuvant trial “Neogem” with enrolment from 2006-2009, not as rapid as hoped. The Neogem phase 2 trial had prospective tissue procurement for translational research and patients with tumours of at lease 3 cm were eligible. Two cohorts were enrolled according to HER2 status. Combining patients with triple negative tumours plus those with hormone receptor-positive HER2-negative phenotype in one cohort, resulted in a lower pathologic complete response (pCR) rate in the HER2-negative cohort than anticipated. More recently there has been recognition that pCR rates in specific HER2-positive and triple negative phenotypes may be the most relevant to outcomes.
Successful recruitment to neoadjuvant therapy trials is enhanced at sites that have pre-operative breast cancer multi-disciplinary meetings, with the opportunity to consider patients with moderate size tumours for neoadjuvant therapy trials prior to surgery. There has been has been gradually increasing enthusiasm for neoadjuvant therapy trials in Australia, although most sites do not have capability for rapid recruitment currently. However, there have been successful examples of single/limited institutions recruiting well to in-house investigator initiated neoadjuvant trials (ie. SETUP trial at Monash/Frankston and NEONAB trial at Geelong, Victoria). Australian sites participated in the recent ETNA phase 3 international neoadjuvant trial, with the Australian participation led by Arlene Chan. In 2015 the ANZBCTG commenced enrolment in an investigator initiated NHMRC funded randomized phase 2 neoadjuvant breast cancer trial “ELIMINATE” with a plan for recruitment at 25 sites.