Abstract LB-320: The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer
Authors: Jennifer Crozier, Adam Brufsky, Ian Grady, Sami Diab, Blanche Mavromatis, Nina D'Abreo, Carrie Dul, Rakhshanda Layeequr Rahman, Sarah Untch, Erin Yoder, Heather M. Kling, Amy M. Truitt, William Audeh, Bastiaan van der Baan
Journal: Cancer Research (2020)

Abstract Background: Genomic expression profiles have enabled the classification of breast cancers into molecular subtypes and provide prognostic information about the metastatic potential of the tumor, both of which have implications for the personalized treatment of breast cancer beyond clinical and pathological features. However, to precisely stratify tumors into actionable subgroups, full genome expression data should be combined with comprehensive clinical information. The FLEX Registry aims to aggregate a large, real-world dataset, which will enable the discovery of novel genomic profiles, particularly for patient subsets that are poorly represented in traditional clinical trials and will contribute to improved precision in the management of breast cancer. Trial Design: The FLEX Registry (NCT03053193) is a multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer. Patients with stage I-III breast cancer who receive MammaPrint, with or without BluePrint, on a primary tumor are eligible for enrollment. The primary objective of FLEX is to create a large scale, population-based registry that links complete clinical data with full genome expression data to elucidate new prognostic and/or predictive gene associations in a real-world setting. The FLEX Registry employs a shared study infrastructure to develop and investigate hypotheses for targeted subset analyses and/or clinical trials based on full genome expression data. The adaptable protocol is designed to be amended with the inclusion of targeted sub-studies. Patients enrolled in the initial study are eligible for inclusion in sub-studies for which they meet all eligibility criteria and additional consent is not required. Data will be collected on patients from diagnosis through 10 years of follow-up and any necessary additional clinical data will be collected as specified in the appendix protocols. Target enrollment is a minimum of 10,000 patients; &amp;gt;4,000 patients have enrolled since April 2017 at more than 80 sites, including seven National Cancer Institute-designated comprehensive cancer centers. The FLEX collaborative platform enables participating investigators the opportunity to author their own sub-study protocols, as approved by the FLEX Steering Committee. Fifteen sub-studies have been approved for investigation within the FLEX Registry. Citation Format: Jennifer Crozier, Adam Brufsky, Ian Grady, Sami Diab, Blanche Mavromatis, Nina D'Abreo, Carrie Dul, Rakhshanda Layeequr Rahman, Sarah Untch, Erin Yoder, Heather M. Kling, Amy M. Truitt, William Audeh, Bastiaan van der Baan, FLEX Investigators Group. The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr LB-320.