Abstract CT260: The FLEX real-world data platform explores new gene expression profiles and investigator initiated protocols in early stage breast cancer
Authors: Brufsky Adam , Crozier Jennifer A. , D'Abreo Nina , Habibi Mehran , Diab Sami , O'Shaughnessy Joyce , Marks Douglas K. , Gadi VK , Truitt Amy M. , Blumencranz Lisa , Yoder Erin , Audeh William , Untch Sarah , van der Baan Bastiaan ,   FLEX Investigators' Group
Published: July 2021

Abstract
Background: Genomic expression profiling has significantly improved the personalized treatment of breast cancer, by providing prognostic information about the metastatic potential of tumors and enabling the classification of breast cancers into molecular subtypes, beyond clinical and pathological factors. When combined with comprehensive clinical data, full genome expression data can precisely stratify tumors into clinically actionable subgroups. The FLEX Study is aggregating a large, real-world dataset, which will enable the discovery of novel genomic profiles to improve precision in the management of breast cancer, particularly in patient subsets that are underrepresented in traditional clinical trials. Methods: The FLEX Study (NCT03053193) is a multicenter network, prospective, observational trial for patients with stage I-III breast cancer whose primary tumor is analyzed by MammaPrint, with or without BluePrint. The primary objective of FLEX is to create a large scale, population-based registry that links comprehensive clinical data with full genome expression data to elucidate new prognostic and/or predictive gene associations in a real-world setting. The FLEX Study employs a shared study infrastructure to develop and investigate hypotheses for targeted subset analyses and/or clinical trials based on genomic data. The adaptable protocol is designed to be amended to include additional targeted sub-studies, allowing participating investigators to leverage data within the FLEX network to investigate research questions. 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 is 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. The target enrollment of FLEX is a minimum of 10,000 patients; over 6,500 patients have enrolled since April 2017 at more than 85 sites, including eight National Cancer Institute-designated comprehensive cancer centers. The FLEX collaborative platform allows participating investigators the opportunity to author their own sub-study protocols, as approved by the FLEX Scientific Review Committee. Sub-study research categories include: Age and Breast Cancer, Optimizing Therapy Strategies, Breast Cancer and Metabolic Syndrome, ctDNA and Liquid Biopsy, Genomics and Subtypes, Social and Ancestry, and Neoadjuvant Therapy and Surgery. To date, 29 investigator-initiated sub-studies have been approved. Trial contact information: NCT03053193 FLEX@agendia.com
Citation Format: Adam Brufsky, Jennifer A. Crozier, Nina D'Abreo, Mehran Habibi, Sami Diab, Joyce O'Shaughnessy, Douglas K. Marks, VK Gadi, Amy M. Truitt, Lisa Blumencranz, Erin Yoder, William Audeh, Sarah Untch, 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 American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT260.