(BPT) - Knowledge is power, and it's also critical for making vital health care decisions. More information leads to better understanding of treatment options, especially when it comes to early-stage breast cancer. To increase knowledge for health care providers and people with breast cancer, the FLEX Study (NCT03053193) from Agendia, provider of MammaPrint® and BluePrint® genomic testing, seeks to capture genomic and clinical data for 30,000 newly diagnosed early-stage breast cancer patients, and to follow them for 10 years.
The FLEX Study captures the entire transcriptome (the complete set of RNA transcripts produced by the genome of an organism at a specific time) from a single breast cancer sample, and combines it with extensive clinical details of each patient — merging crucial genomic data with clinical data to create a huge database unlike any previous registry.
As of May 2025, the FLEX study has enrolled over 20,000 early-stage breast cancer patients across 102 sites in the U.S., three sites in Canada and one site each in Greece and Israel. This makes it the most diverse study to date, with significant representation from a wide array of populations to make FLEX much more inclusive of minority groups that have been previously underrepresented in medical research.
Open to women and men 18 years and older who have been diagnosed with stage I, II or III breast cancer, including all clinical subtypes, the FLEX dataset will be a true representation of the entire patient population. FLEX is the largest and most comprehensive observational trial for breast cancer, drawing on a vast database of genomic and clinical data to offer ongoing insights that can help inform care decisions for people with breast cancer today and into the future.
"The study is already providing a very valuable tool to help health care providers predict patient responses to therapy," said Joyce O'Shaughnessy, MD, FLEX National Principal Investigator, chair of the Breast Cancer Program for U.S. Oncology Research, Texas Oncology and Celebrating Women chair in Breast Cancer Research at Baylor University Medical Center, Dallas, Texas. "This data also helps us understand the mechanisms of treatment in early-stage breast cancer patients, with long-term follow-up."
Expanding understanding of early-stage breast cancer
The FLEX trial focuses on enriching enrollment of diverse racial/ethnic minorities, historically underrepresented groups and uncommon early breast cancer (EBC) tumor histologies (the scientific study of the microscopic structure of cells and tissues). An additional goal is supporting investigator-initiated sub-studies to address clinically relevant questions in EBC with up to 10 years of follow-up.
By capturing data from patients of all ethnicities, ages, genders and health statuses, the FLEX database provides valuable opportunities to accelerate real-world breast cancer research. FLEX will enable researchers to investigate the differences and trends between breast cancer sub-groups. Importantly, it will also allow a focus on smaller, more diverse patient populations which have traditionally been challenging to recruit in sufficient numbers for clinical trials.
Patients who receive standard of care MammaPrint® (70-gene signature risk of recurrence), with or without BluePrint® (80-gene signature molecular subtype) genomic testing on their primary breast tumor and consent to clinically annotated whole transcriptome data collection are eligible for enrollment.
Ongoing research is already uncovering key insights
The FLEX trial is currently supporting ongoing research, including 42 active sub-studies, and has presented over 63 abstracts internationally (2018-2025), including 6 podium presentations that address the underlying differences in tumor biology and disparities in treatment in underrepresented populations.
At this year's San Antonio Breast Cancer Symposium® (SABCS), several presentations will reveal the latest research insights discovered from analysis of FLEX data. SABCS is the world's largest and most significant scientific conference exclusively dedicated to breast cancer, providing a vital platform for clinicians and researchers to share new data, discuss medical discoveries and collaborate globally, attracting over 10,000 attendees from more than 102 countries.
Presentations at the 2025 SABCS highlight the key role of FLEX study data in providing detailed insights that can help health care providers recommend treatment options for individuals, depending on their unique risk factors for disease recurrence in early breast cancer.
"The scientific evidence being developed by the FLEX data means that health care teams can provide personalized care that helps them minimize both over- and under-treatment of an individual's disease," added O'Shaughnessy.
Evidence-based insights from the FLEX study and genomic testing are resulting in more personalized treatment planning at the earliest stage of care, leading to better informed treatment decisions and improved patient outcomes.
Learn more about the latest insights from the FLEX registry at Agendia.com.
