If you wanted to know everything about breast cancer, where would you begin? As with many cancers, there is too much complexity to select a single aspect, such as genomics, tissue profiling, clinical history… A truly comprehensive study must capture every facet of the disease – and that’s the aim of the FLEX breast cancer registry. The survey is a prospective, observational study that combines full-genome profiling with clinical data. It seeks to enroll 10,000 patients with stage I, II, or III breast cancer and follow them over the course of a decade. There are no limits on who may join the study: men and women of any age and from any ethnic group are welcome. Bastiaan van der Baan, Chief Clinical and Business Development Officer at precision oncology company Agendia, explains FLEX in more detail.
How long will the project take?
The FLEX breast cancer registry survey is set up to be a standing trial – so, as long as there are questions outstanding in relation to improving breast cancer care, it will continue to recruit patients. It collects universal clinical data and full genome data to help us understand the course of the disease and its response to therapy to find the right treatment for the right patients at the right time.
Often, involvement in clinical trials can involve extra process steps; however, FLEX has been set up in a way that makes the burden for the clinic relatively small, so non-academic sites can participate with minimal additional work. And because these sites generally see the majority of breast cancer patients, they will generate a significant amount of real-world evidence.
What kinds of gene associations do you hope to find?
The possibilities for data analysis and exploration are limited only by the population of patients entered into the FLEX registry. Because these are primarily early-stage patients with clinical details and follow-up, we can explore genomic diversity within subtypes of breast cancer. We can explore the gene signatures associated with outcomes and with sensitivity and resistance to specific therapy regimens. We can even look at the differences in breast cancer gene expression patterns between women of different genetic backgrounds, as well as a variety of clinical subsets in which there is an urgent need for in-depth genomic information.
FLEX is a US-only trial at present, but we have a very similar registry study – PRECiSE – ongoing in the Netherlands. I hope that these projects will accelerate the implementation of new insight. It still takes a lot of time to implement new diagnostic, prognostic, and predictive data – but we hope these platform trials will change that.
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