Abstract OT3-17-02: The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer
Authors: Crozier Jennifer A , Srkalovic Gordan , Brufsky Adam , Habibi Mehran , Whitworth Pat , Cox Charles , Grady Ian , Lomis Thomas , D'Abreo Nina , Yoder Erin B , Untch Sarah , Kling Heather , Audeh William , Van der Baan Bastiaan ,   FLEX Investigators Group
Published: March 2020

Abstract
Background discussion: Genomic signatures are revolutionizing the definition, identification, and treatment of breast cancer. To precisely stratify breast cancers into actionable subgroups, full genome (FG) expression data and matching clinical data must be aggregated into a large, real-world dataset. Such a dataset will accelerate research and discovery, especially for smaller patient subsets that are not as widely represented within the current body of literature.
Trial design and aims: FLEX is a multicenter, prospective, population-based, observational trial for patients with Stage I, II, and III breast cancer. All patients with stage I to III breast cancer who receive MammaPrint (MP), with or without BluePrint (BP) on a primary breast tumor are eligible for enrollment. The study’s primary aim is to create a large scale, population-based registry of full genome expression data matched with clinical data to investigate new gene associations with prognostic and/or predictive value in a real-world setting. Secondary objectives include utilizing the shared study infrastructure to examine and generate hypotheses for targeted subset analyses and/or trials based on full genome expression data.
The design of FLEX allows targeted sub-studies and sub-analyses to be added as appendices after the initial baseline study is opened. Data collection follows patients from diagnosis through 10 years of follow-up. Patients enrolled in the initial study are also eligible for inclusion in sub-studies for which they meet all criteria and additional consent is not required. Additional clinical data will be collected as specified in the appendix protocols. The FLEX collaborative platform allows participating investigators the opportunity to author their own sub-study protocols, as approved by the FLEX Steering Committee of their peers. 14 sub-studies have already been identified and approved (Table 1).
Eligibility and accrual: The study will enroll a minimum of 10000 patients aged ≥18 years with histologically proven invasive stage I, II, or III breast cancer. Since April 2017 over 2362 patients have been enrolled.
Trial contact information:
NCT03053193
FLEX@agendia.com
TABLE 1PIINSTITUTIONTYPEADDITIONAL CONSENTARM(S)DESCRIPTIONMehran HabibiJohns HopkinsLocal SubstudyYesNeoadjuvantComprehensive gene expression profiling of breast cancer in patients receiving short-course endocrine therapy prior to surgeryMehran HabibiJohns HopkinsLocal SubstudyYesAllCorrelation of the microbiome with breast cancer gene expressionThomas LomisValley Breast ClinicCollaborative group substudyYesNeoadjuvantComplementary data collection for patients participating in the ODM-201 trial. FLEX will provide gene expression profiling for exploratory and signature discovery purposesIan GradyNorth Valley Breast CareSubstudyNoAllImpact of genomic risk classification on travel time to receive breast cancer care: a QOL studyPat WhitworthNashville Breast CenterSubstudyNoNeoadjuvantGenomic reclassification of large tumors in patients eligible to receive neoadjuvant therapyAdam BrufskyUniversity of Pittsburgh Medical CenterSubstudyNoNeoadjuvant, adjuvantResponse to standard chemotherapy regimens in clinically ER+/PR+/HER2+ (triple positive) patients according to BluePrint molecular subtypesAdam BrufskyUniversity of Pittsburgh Medical CenterSubstudyNoAllExpression signatures by response to bisphosphonates in ER+ patients receiving adjuvant therapy (SOC option), or for osteoporosis after primary treatmentAdam BrufskyUniversity of Pittsburgh Medical CenterSubstudyNoAllGene expression in breast cancer patients with obesityJennifer A. CrozierBaptist MD Anderson Cancer CenterSubstudyNoAllMP and BP in male breast cancerJennifer A. CrozierBaptist MD Anderson Cancer CenterSubstudyNoAllMP and BP evaluation in breast cancer patients ≥70Jennifer A. CrozierBaptist MD Anderson Cancer CenterSubstudyNoAllFG evaluation in invasive lobular carcinomaJennifer A. CrozierBaptist MD Anderson Cancer CenterSubstudyNoAllMP and BP relation to clinical PR positivityJennifer A. CrozierBaptist MD Anderson Cancer CenterSubstudyNoAllMP and BP relation to clinical Ki67 scoreJennifer A. CrozierBaptist MD Anderson Cancer CenterSubstudyNoAllMP and BP in metaplastic breast cancer
Citation Format: Jennifer A Crozier, Gordan Srkalovic, Adam Brufsky, Mehran Habibi, Pat Whitworth, Charles Cox, Ian Grady, Thomas Lomis, Nina D'Abreo, Erin B Yoder, Sarah Untch, Heather Kling, 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 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-17-02.