Abstract OT2-07-01: The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early-stage breast cancer

Abstract Background: Genomic signatures provide prognostic information such as tumor metastatic potential, outperforming information gained from clinicopathologic factors alone, which has transformed personalized treatment of early breast cancer. Together, whole genome expression data can accurately stratify tumors into clinically actionable molecular subtypes. The FLEX study (NCT03053193) is a large, real-world dataset, combining whole genome expression with clinically annotated data, to accelerate research and discovery of subgroups in breast cancer. The goal of FLEX is to discover and develop novel genomic profiles that bring precision oncology to the clinic, and ultimately improve treatment and outcomes of patients with breast cancer. Study Design: The FLEX study is a multicenter, prospective observational trial of patients aged ≥ 18 years with stage I-III breast cancer who receive MammaPrint, with or without BluePrint. Patients consent to the acquisition of clinical data and clinically annotated full transcriptome tumor analysis. The FLEX study creates a unique infrastructure to develop and investigate hypotheses for targeted subset analyses and/or clinical trials. In doing so, the adaptive protocol allows submission of investigator-initiated sub-studies. Upon approval by a Scientific Review Committee, FLEX investigators can query the clinical and genomic data in FLEX to investigate hypotheses for targeted subset analysis. Patients enrolled in the original study who meet all eligibility criteria may be enrolled in sub-studies without additional consent. All necessary clinical data will be collected from patients, starting from diagnosis through 10-year follow-up. Sub-study research categories include: breast cancer and age, optimization of therapeutic strategies, breast cancer tumor types, biomarker identification and quality of care. The FLEX enrollment goal is a minimum of 30,000 patients within 10 years; since April 2017, more than 7,500 patients were enrolled at more than 90 sites. Participating sites include community hospitals and nine National Cancer Institute-designated comprehensive cancer centers to ensure inclusion of diverse populations, particularly patient populations that are underrepresented in traditional clinical trials. Most recently, the FLEX network was expanded globally with additional sites in Greece and Israel. To date, 38 investigator-initiated sub-studies have been approved, resulting in 23 published abstracts at national congresses. Trial contact information: NCT03053193, FLEX@agendia.com Citation Format: Cynthia X. Ma, Robert Maganini, Pat Whitworth, Jennifer A. Crozier, Joyce O'Shaughnessy, Sami Diab, Beth-Ann Lesnikoski, June Lee, Nina D'Abreo, Blanche H. Mavromatis, Pond Kelemen, Darina Pronin, Hiwot Abebe, Michelle L. Bolner, Christine Finn, Lisa Blumencranz, William Audeh, 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 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-07-01.