Problem statement: Evidence to support use of multi-parameter tumour gene expression assays (MPAs) in node positive, early breast cancer and for premenopausal breast cancer is not robust. The OPTIMA (Optimal Personalised Treatment of early breast cancer usIng Multi-parameter Analysis) (ISRCTN42400492) trial aims to validate test directed chemotherapy use in mostly node-positive breast cancer.
Methods: OPTIMA is a prospective, international, randomised controlled and partially blinded study that recruits people aged ≥40 years with resected oestrogen receptor-positive, HER2-negative tumours and up to 9 involved lymph nodes. Randomisation is to standard management (chemotherapy and endocrine therapy) or MPA-directed treatment using the Prosigna test. Those with Prosigna tumour Scores (ROR_PT) >60 receive standard management whilst those with lower score tumours receive endocrine therapy alone. Pre-menopausal participants receive ovarian suppression as part of their endocrine therapy. Adjuvant abemaciclib is permitted. The trial will be analysed for (1) non-inferiority of recurrence (IBCFS) Per Protocol according to randomisation and (2) cost-effectiveness. The key secondary outcome is non-inferiority of recurrence for patients with tumour ROR_PT scores ≤60. Recruitment of 4500 patients over 8 years will permit demonstration of up to 3% non-inferiority of test-directed treatment with at least 83% power, assuming 5-year IBCFS is 87% with standard management. Commencing in late 2022 OPTIMA will be activated in up to 50 sites throughout Australia and New Zealand.
Results: OPTIMA opened in January 2017. Overall recruitment as of 27th Septemer 2022 was 3003 patients out of the 4500 target. Currently 95% of randomised participants are eligible for inclusion in the per protocol analysis. 66% of the MPA-directed arm participants have been allocated to endocrine therapy only. The test failure rate is <1%.
Conclusion: OPTIMA will provide robust unbiased evidence on test-directed chemotherapy safety for both postmenopausal and premenopausal women with 1-3 involved nodes as well as for patients with 4-9 involved nodes.
OPTIMA is funded by the UK NIHR HTA Programme.

**Problem statement:** Evidence to support use of multi-parameter tumour gene expression assays (MPAs) in node positive, early breast cancer and for premenopausal breast cancer is not robust. The OPTIMA (Optimal Personalised Treatment of early breast cancer usIng Multi-parameter Analysis) (ISRCTN42400492) trial aims to validate test directed chemotherapy use in mostly node-positive breast cancer.
**Methods:** OPTIMA is a prospective, international, randomised controlled and partially blinded study that recruits people aged ≥40 years with resected oestrogen receptor-positive, HER2-negative tumours and up to 9 involved lymph nodes. Randomisation is to standard management (chemotherapy and endocrine therapy) or MPA-directed treatment using the Prosigna test. Those with Prosigna tumour Scores (ROR_PT) >60 receive standard management whilst those with lower score tumours receive endocrine therapy alone. Pre-menopausal participants receive ovarian suppression as part of their endocrine therapy. Adjuvant abemaciclib is permitted. The trial will be analysed for (1) non-inferiority of recurrence (IBCFS) Per Protocol according to randomisation and (2) cost-effectiveness. The key secondary outcome is non-inferiority of recurrence for patients with tumour ROR_PT scores ≤60. Recruitment of 4500 patients over 8 years will permit demonstration of up to 3% non-inferiority of test-directed treatment with at least 83% power, assuming 5-year IBCFS is 87% with standard management. Commencing in late 2022 OPTIMA will be activated in up to 50 sites throughout Australia and New Zealand.
**Results:** OPTIMA opened in January 2017. Overall recruitment as of 27th Septemer 2022 was 3003 patients out of the 4500 target. Currently 95% of randomised participants are eligible for inclusion in the per protocol analysis. 66% of the MPA-directed arm participants have been allocated to endocrine therapy only. The test failure rate is <1%.
**Conclusion:** OPTIMA will provide robust unbiased evidence on test-directed chemotherapy safety for both postmenopausal and premenopausal women with 1-3 involved nodes as well as for patients with 4-9 involved nodes.
OPTIMA is funded by the UK NIHR HTA Programme.

OPTIMA, A PROSPECTIVE INTERNATIONAL RANDOMIZED TRIAL TO VALIDATE THE CLINICAL UTILITY AND COST-EFFECTIVENESS OF GENE EXPRESSION TEST-DIRECTED CHEMOTHERAPY IN HIGH CLINICAL RISK EARLY BREAST CANCER.

We are pleased to welcome you to the Australasian International Breast Congress (AIBC) held jointly with the [Australasian Society for Breast Disease (ASBD)](https://www.asbd.org.au/),[6th World Congress on Controversies in Breast Cancer (CoBrCa)](http://cobrca.org/) and [Breast Surgeons of Australia and New Zealand (BreastSurgANZ) in Brisbane, Australia](https://www.breastsurganz.org/).

The Joint Congress will continue the tradition of directly addressing key issues facing clinicians in their daily practice, including medical oncology, surgery, radiation oncology, breast imaging, pathology, reconstruction, allied health and survivorship issues.

We are delighted to have assembled a stellar international and national faculty and thank all those who have agreed to participate and those who have submitted abstracts. We trust that the program is an informative and enjoyable experience.

Thank you for joining us.