CLINICAL DATA
20+ years of clinical validation. 200 research collaborations. 100s of publications.
Championing the value of Big Data.
As a leader in precision oncology, we are constantly driving innovation with challenging new studies and collaborations with prestigious partners. We are committed to further research in the clinical applications of genomics and other technologies that may improve patient outcomes.
FLEX has the potential to become one of the most valuable and impactful national datasets in breast cancer research.
— Joyce O’Shaughnessy, MD
Chair of the Breast Cancer Program for US Oncology Research, Texas Oncology and Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Dallas, TX
FLEX Study
Overview
A large-scale, prospective, observational breast cancer study that links full genome profiling, including MammaPrint and BluePrint, with complete clinical data. FLEX has created a comprehensive patient database with the potential to identify new gene associations with prognostic and/or predictive value in breast cancer.
The primary goal of this project is to capture genomic and clinical data for 30,000 breast cancer patients and to follow them for more than 10 years.
Open to both women and men diagnosed with stage I, II, or III cancer, including all clinical subtypes, the dataset will be a true representation of the entire patient population. 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.
Findings
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. To date, more than 30 presentations of the data have been showcased at major oncology conferences globally.
Current FLEX Sites in the US
I-SPY2 Trial
Overview
I-SPY2 breaks from the traditional randomized trial format, employing an ‘adaptive’ model that allows multiple treatments (up to six different agents) to be studied in parallel. This master framework also allows new agents to enter and leave the study without having to halt enrollment or resubmit the entire clinical trial protocol for regulatory review.
I-SPY2’s innovative design sets a new benchmark for efficiency in phase II clinical trials, by minimizing the number of participants and time required to evaluate each experimental agent. Widely regarded as a pioneer of the ‘platform’ trial, I-SPY2 is a major influence on the development of next-generation trial designs in oncology and beyond.
Findings
Data from the I-SPY studies has been presented at global oncology conferences and used to graduate novel treatments to phase III clinical trials.
LESS Study
Overview
LESS is a single-arm study to evaluate the de-escalation of adjuvant endocrine therapy in women with HR+ HER2- breast cancer with MammaPrint® Ultra Low Risk of metastasis*. UNICANCER in France is the sponsor of the LESS study, which will enroll patients in up to 50 French sites. The purpose of this study is to demonstrate that adjuvant endocrine therapy limited to 2 years of aromatase inhibitor, instead of the standard 5 years, can ensure high survival without metastatic relapse and allows a better quality of life. Post-menopausal women with HR+/HER2- invasive early-stage breast cancer, and a MammaPrint UltraLow Risk tumor, are eligible. The protocol is publicly available, via https://clinicaltrials.gov/ct2/show/NCT05297617.
For more information on MammaPrint and our collaboration with UNICANCER, please contact: customerservice@agendia.com
*UltraLow is a threshold within the MammaPrint Low Risk category. Patients with ER+HER2- breast cancer and an UltraLow MammaPrint Risk have excellent prognosis (breast cancer specific survival) at 20 years with limited duration or without any endocrine therapy (Breast Cancer Clinical Trials – Agendia’s Landmark Trials)
