Background: While the overall prognosis for early breast cancer (EBC) is excellent there is a still risk of distant recurrence and death from metastatic disease. The AllClear program was established in 2025 to reduce breast cancer (BC) deaths by identifying, characterising, and testing new treatments to eliminate, dormant cancer cells that can lead to distant recurrence and BC death. Information about the characteristics, treatment and outcomes of people with EBC managed in routine care is essential to inform this work, but data are sparse. We designed the AllClear-Real-world evidence (RWE) program to address this gap.
Aim: To describe the baseline characteristics of people diagnosed with EBC in NSW 2005-2019, and compare to clinical trial cohorts.
Methods: The AllClear-RWE cohort includes all adults with a first diagnosis of EBC 2005-2019 in NSW. We used the Medicines Intelligence Data Platform to obtain data from cancer registrations linked to administrative hospital records, Pharmaceutical Benefit Scheme (PBS) and Medicare Benefit Schedule claims and deaths. We used PBS medicine dispensing to define tumour receptor-status at 12-months (landmark). We describe cohort characteristics and compare to clinical trial cohorts.
Results: The AllClear-RWE EBC cohort includes 60,936 people: node-negative:59%; ductal:74%; born outside Australia:32%; living outside major cities:31%; males:0.6%. In the eligible treated population: ER+HER2- 76%; ER+HER2+ 7%; ER-HER2+ 5%; triple-negative 11%. The majority were aged 50-69 years at diagnosis, n=32,193(53%); <40 years 2,945(5%); 40-49 years 10,378(17%). One-quarter were ≥70 years (n=15,420); this group is poorly represented in trials cited in EBC guidelines.
Conclusion: AllClear-RWE provides valuable population-based data to understand the diversity of people living with EBC, including for people under-represented in trials. We will examine treatment patterns and cancer outcomes in future studies. The AllClear-RWE program can inform clinical care and policy initiatives to improve cancer data and EBC care to support equitable outcomes.