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 10,000 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 20 presentations of the data have been showcased at major oncology conferences globally.

Current FLEX Sites in the US


Learn more about The Flex Study
Contact Us About The Flex Study

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.

Learn more about the I-SPY Trials

PRECiSE Study

Overview

PRECiSE will harvest the power of full genome gene expression with the outstanding Dutch Cancer Registry that houses comprehensive clinical data of all cancer patients in the Netherlands. Under the management of the Dutch Clinical Trial organization BOOG, together with 28 hospitals and Agendia, we aim to enroll 1000 patients in the first phase of this project, and to make this data set available for researchers in The Netherlands. Stage I and II breast cancers that are eligible for MammaPrint can be enrolled in this registry trial. First findings are expected early in 2022 when we have completed our enrollment.


Learn more about The PRECISE Study