1. LaCorte, Sarah

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Researchers at the SABCS 2020 Annual Meeting gave an update on the FLEX registry, a large-scale, population-based registry that links comprehensive clinical data with full genome expression data to elucidate new prognostic and predictive gene associations in a real-world setting (Poster OT-12-01).

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"Gene expression profiles have enabled the classification of breast cancers into molecular subtypes with distinct clinical outcomes, which has significant implications for patient stratification and treatment strategy," said Laura Lee, MD, a specialist in breast surgery, general surgery, and oncology surgery at the Comprehensive Cancer Center at Desert Regional Medical Center in Palm Springs.


"However, there are several challenges in implementing gene signatures into clinical practice. One of the challenges is excision of full genomic expression data that is annotated with comprehensive clinical data. This is the foundation of the FLEX study protocol."


Study Details

According to the poster session presented as SABCS, the FLEX Registry (NCT03053193) is a multi-center, prospective, observational trial for patients with stage I-III breast cancer whose primary tumor is analyzed by MammaPrint, with or without BluePrint. The FLEX Registry uses a shared study infrastructure to develop and investigate hypotheses for targeted subset analyses and clinical trials based on full genome expression data.


"Based on the recommended standard of care, patients will fall into one of three study arms: neoadjuvant treatment, adjuvant treatment, and non-surgical disease monitoring. FLEX is agnostic to breast cancer subtype, management plan, and treatment regimen," said Lee. "Baseline pathology data, imaging information, and patient history are collected prior to genomic testing. After MammaPrint and BluePrint are reported, information about treatment plan is collected. After completion of treatment, surgical pathology treatment regime and other clinical parameters are collected. Follow-up data is collected at 3, 5, and 10 years."


The target enrollment of FLEX is a minimum of 10,000 patients; over 5,000 patients have enrolled since accrual began in April 2017 at more than 85 sites, including eight National Cancer Institute-designated comprehensive cancer centers. Lee added that over 800 clinical data points including demographic information, patient history, metabolic and pathologic factors, and pre-treatment imaging are collected along with the full genomic data.


The FLEX collaborative platform allows participating investigators the opportunity to author their own sub-study protocols, as approved by the FLEX Review Committee.


"The rapid rate of data accrual using this platform has enabled multiple investigator-initiated sub-studies of clinical significance... Fifty-nine proposed sub-studies have been submitted; 27 are in progress. These sub-studies cover topics like identifying novel gene expression signatures associated with response to neoadjuvant therapy, optimization of therapeutic strategies, and refining the heterogeneity of breast cancer sub-groups," Lee said.


"Enough data has already been collected to study patient subsets previously poorly represented in traditional clinical trials, including male breast cancer, metaplastic breast cancer, breast cancer in the elderly, and breast cancer in patients of African-American ancestry.


"The FLEX registry is generating a large, real-world dataset which will enable discovery of novel genomic profiles that will improve personalized treatment for breast cancer," Lee concluded.


Sarah LaCorte is associate editor.