15 TiP The FLEX Real-World Data Platform Explores New Gene Expression Profiles and Investigator-Initiated Protocols in Early-Stage Breast Cancer

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement38th Annual Miami Breast Cancer Conference® - Abstracts
Volume 35
Issue suppl 1
Pages: 43

Pat Whitworth, MD1

1Ascension Saint Thomas Hospital Midtown, Nashville, TN

Background

Genomic expression profiling has transformed breast cancer treatment by providing prognostic information beyond clinical-pathological factors, including metastatic potential of tumors. When combined with comprehensive clinical information, full genome expression data can precisely stratify tumors into clinically actionable subgroups. The FLEXstudyisa large, aggregate real-world data set that comprises full genome expression data combined with annotated clinical data to accelerate research and discovery among breast cancer subsets. Discovery of novel genomic profiles will improve precision in the management of breast cancer, particularly in patient subsets that are underrepresented in traditional clinical trials.

Materials and Methods

The FLEXstudy(NCT03053193) is a multicenter, prospective, observational trial for patients with stage I, II, and III breast cancer whose primary tumor is analyzed by MammaPrint, with or without BluePrint.The primary objective of FLEX is to investigate novel gene associations of prognostic and/or predictive value through development of a large-scale, population-based registry incorporating full genome expression data matched with comprehensive clinical data. The FLEX study supports the inclusion of targeted substudies, allowing for participating investigators to leverage the FLEX network to explore research questions based on full genome expression data. The FLEX collaborative platform allows participating investigators the opportunity to author their own substudy protocols, as approved by the FLEX Scientific Review Committee. Patients enrolled in the initial study are eligible for inclusion in substudies for which they meet all eligibility criteria, and additional consent is not required. Data are collected on patients from diagnosis through 10 years of follow-up; any necessary additional clinical data will be collected as specified in the appendix protocols.

Trial Status

The FLEX study aims to enroll a minimum of 25,000 patients meeting eligibility criteria. As of January 2021, more than 6500 patients have been enrolled from more than 85 sites, including 9 National Cancer Institute–designated Comprehensive Cancer Centers. Currently, substudy 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 substudies have been approved.

Trial contact information:

NCT03053193

FLEX@agendia.com

Articles in this issue

1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population
1 The Tolerance of CREATE-X Capecitabine Dosing in a United States TNBC Patient Population
6 Survival Benefit of Eribulin, But Not Capecitabine, for Metastatic Breast Cancer Is Associated With Baseline Absolute Lymphocyte Count in Peripheral Blood
6 Survival Benefit of Eribulin, But Not Capecitabine, for Metastatic Breast Cancer Is Associated With Baseline Absolute Lymphocyte Count in Peripheral Blood
7 Evaluation of the 21-Gene Recurrence Score (RS) Assay Results Following Successful Intraoperative Radiation Therapy (IORT) Treatment of Patients With Early-Stage Breast Cancer
7 Evaluation of the 21-Gene Recurrence Score (RS) Assay Results Following Successful Intraoperative Radiation Therapy (IORT) Treatment of Patients With Early-Stage Breast Cancer
8 Concordance of Tumor Response with Eribulin Use in Real-World Clinical Practice
8 Concordance of Tumor Response with Eribulin Use in Real-World Clinical Practice
13 Real-world Treatment Patterns and Tumor Response of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
13 Real-world Treatment Patterns and Tumor Response of Palbociclib Plus an Aromatase Inhibitor for Metastatic Breast Cancer: Flatiron Database Analysis
14 Real-World (RW) Treatment Patterns and Clinical Effectiveness of Palbociclib (PAL) Plus an Aromatase Inhibitor (AI) as First-Line Therapy in Advanced/ Metastatic Breast Cancer (A/MBC): Analysis From Syapse Learning Health Network
14 Real-World (RW) Treatment Patterns and Clinical Effectiveness of Palbociclib (PAL) Plus an Aromatase Inhibitor (AI) as First-Line Therapy in Advanced/ Metastatic Breast Cancer (A/MBC): Analysis From Syapse Learning Health Network
25 A Retrospective Cohort Study of Demographic, Clinical, and Treatment Characteristics of Patients With Metastatic Breast Cancer Who Have Received PARP Inhibitors
25 A Retrospective Cohort Study of Demographic, Clinical, and Treatment Characteristics of Patients With Metastatic Breast Cancer Who Have Received PARP Inhibitors
28 Primary Outcome Analysis of Invasive Disease-Free Survival for monarchE: Abemaciclib Plus Adjuvant Endocrine Therapy for High-Risk Early Breast Cancer
28 Primary Outcome Analysis of Invasive Disease-Free Survival for monarchE: Abemaciclib Plus Adjuvant Endocrine Therapy for High-Risk Early Breast Cancer
30 Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Early- Stage Breast Cancer (ESBC) Receiving Docetaxel and Cyclophosphamide
30 Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Early- Stage Breast Cancer (ESBC) Receiving Docetaxel and Cyclophosphamide
35 Decreased Epithelial Mesenchymal Transition Process After AGTR-1 Gene Edition By Crispr/Cas9, Losartan, and PARP Inhibitor Treatment In Breast Cancer Cell Line
35 Decreased Epithelial Mesenchymal Transition Process After AGTR-1 Gene Edition By Crispr/Cas9, Losartan, and PARP Inhibitor Treatment In Breast Cancer Cell Line
37 Treatment Outcomes Using Neoadjuvant Chemotherapy for HER2-Positive Breast Cancer in African American and Hispanic Women
37 Treatment Outcomes Using Neoadjuvant Chemotherapy for HER2-Positive Breast Cancer in African American and Hispanic Women
42 The United States Retrospective Claims Database Analysis of Demographic, Clinical, and Treatment Characteristics of Metastatic Breast Cancer Patients receiving Olaparib
42 The United States Retrospective Claims Database Analysis of Demographic, Clinical, and Treatment Characteristics of Metastatic Breast Cancer Patients receiving Olaparib
43 Lobular Cancer Responsiveness to Chemotherapy Is Equivalent to That of Ductal Cancer With Similar Genomic Profiles: An NCDB Analysis
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44 Drivers of Oncologist Treatment Selection in HR+/HER2- Metastatic Breast Cancer
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