Breast
Cathy L. Graham, MD
Director Breast Surgery Northern Arc
Emory University Winship Cancer Institute ESJH
Atlanta, Georgia, United States
Cathy L. Graham, MD
Director Breast Surgery Northern Arc
Emory University Winship Cancer Institute ESJH
Atlanta, Georgia, United States
Cathy L. Graham, MD
Director Breast Surgery Northern Arc
Emory University Winship Cancer Institute ESJH
Atlanta, Georgia, United States
Joyce O’ Shaughnessy, MD
Celebrating Women Chair in Breast Cancer Research
Baylor University Medical CenterTexas Oncology, US Oncology Network, Dallas, TX, USA, United States
Danijela Jelovac, MD
medical oncologist
JJohns Hopkins, Maryland, United States
William Audeh, MD, MS
Chief Medical Officer
Agendia, Inc., United States
Victoria Poillucci,, DNP, EMd, MSN, ACNP-BC
Director of Medical Education and Communication, Medical Science Liaison
Agendia, Inc., United States
Karen Tedesco, MD
medical oncologist
US Oncology, United States
Olexiy Aseyev, MD, PhD
medical oncologist
Northern Ontario School of Medicine, United States
Sarah Thayer, MD PhD
Director Feist-Weiller Cancer Center
Ochsner-LSU Health, United States
Laila Samiian, MD
Chief of Breast Surgery
University of Florida Academic Health Center, United States
Lee Riley, MD, PhD
Surgical Oncologist
St. Luke's University Health Network, United States
Jose Jaime Alberty-Oller, MD FACS
Physician
Kings County Hospital NYCHHC, United States
Clinical trials have been critical for discovery, treatment, and quality of life for breast cancer patients. The MammaPrint (MP) 70-gene assay and BluePrint (BP) 80-gene subtype are clinical tools used in treatment planning in breast cancer. Historically, trial populations have not been racially diverse. Efforts to improve diversity and inclusion, efficacy and health equity across races/ethnicities are critical. MP and BP have been shown to identify genomic and outcome differences in black women. The ongoing multi-center FLEX trial (NCT03053193) has proven clinical usefulness among a very diverse population. With a target enrollment of 30,000 patients, the collaborative research network within FLEX uses MP, BP, full transcriptome and clinical data to explore clinical and genomic differences in (sub)populations of interest to promote and advance precision medicine for patients with early-stage breast cancer.
Methods:
FLEX links clinical data with full transcriptome data. It is a prospective, observational trial for patients ≥ 18 years old with histologically proven stage I-III breast cancer with 0-3 positive nodes. Patients have standard of care MP +/- BP and consent to clinically annotated full transcriptome data collection. The study’s infrastructure facilitates the generation of hypotheses for targeted sub-studies that affect breast cancer management. The FLEX trial fosters collaboration with 99 active sites, including Canada, Greece, and Israel. All proposed sub-studies are vetted and approved by both internal and external research and scientific review committees.
Results:
Since April 2017, 14,994 patients have been enrolled: Black n=1225; Latin n=386; AAPI n=318. 43 investigator-initiated sub-studies have been approved involving MP/BP clinical utility, racial disparities, and neoadjuvant planning in ER+, and/or HER2+ disease. 31 abstracts have been accepted in national and international congresses. Five ongoing sub-studies within FLEX address differences in underlying biology and treatment response/management among Black, Latina, and Asian American patients. These studies provide a broader understanding of how differential gene expression patterns, identified with MP/BP, are unique to racial/ethnic groups and can impact outcomes.
Conclusions:
The FLEX study strives to use MammaPrint, BluePrint, and newly developed immune signature, ImPrint, along with full transcriptome data to improve precision medicine in early-stage breast cancer.