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.

The study is providing a very valuable tool to prognosticate and predict response to therapy, and to interrogate the mechanisms of treatment resistance across many thousands of early-stage breast cancer patients, with long follow-up.

โ€” Joyce Oโ€™Shaughnessy, MD, FLEX National PI

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 (NCT03053193)

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.

As of September 2024, FLEX has enrolled 18,187 early-stage breast cancer patients, making it the most diverse study to date, with significant representation from Black, Latin American/Hispanic, and AAPI groups. The trial is currently supporting 42 active sub-studies and has presented over 45 abstracts internationally (2018-2024), including 11 presentations and 2 poster spot-light sessions that address the underlying differences in tumor biology and disparities in treatment in underrepresented populations.โ€‹

Current FLEX Sites in the US


SWOG S2206 (NCT06058377) Trial

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for MammaPrint High 2 (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Overview

This trial is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. The trial will be led by NCI-funded SWOG Cancer Research Network with the participation of the NCI-funded National Clinical Trials Network (NCTN) organizations: Alliance for Clinical Trials in Oncology; ECOG-ACRIN Cancer Research Group; and NRG Oncology.

  • Study Principal Investigator: Dr. Erin Cobain (University of Michigan)
  • MammaPrint High Risk 2 is the biomarker in this trial

Trial Primary Objective

To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab.


Dr. Erin Cobain

โ€œWe have known for many years that gene expression profiling tests such as MammaPrint can be used in the clinic to determine if chemotherapy treatment will improve the likelihood of cure for patients with estrogen receptor positive breast cancer,โ€ said Dr. Cobain. โ€œWe now have emerging evidence to suggest that gene expression profiling may also help identify which estrogen receptor positive breast cancers benefit from immunotherapy treatment. The goal of this study is to further increase the likelihood of cure by delivering immunotherapy to the patients most likely to benefit based on the unique features of their tumor.โ€ย  ย – Erin Cobain, MD, University of Michigan, S2206 Principal Investigator



INSIGHT Trial (NCT05693766)

Overview

The Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT) Trialis an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC).

  • Study principal investigator: Sonya Reid, MD, MPH, Vanderbilt University/Ingram Cancer Center
  • Study Sponsor: Sonya Reid
  • Collaborators: Susan G. Komen Breast Cancer Foundation
  • Inclusion criteria include: tumors diagnosed as non-Luminal A using Blueprintยฎ and Mammaprintยฎ gene expression profiling tests

Trial Primary Objective

Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer.

I-SPY2 Trial

Overview

I-SPY2 breaks from the traditional randomized trial format, employing an โ€˜adaptiveโ€™ 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-SPY2โ€™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 โ€˜platformโ€™ 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.

DEBRA Trial (NCT04852887)

Overview

This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or
non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy.

  • Study Sponsor: NRG Oncology
  • Collaborators: National Cancer Institute (NCI)
  • Inclusion criteria include MammaPrint Low Risk results (includes Low and UltraLow)

Trial Primary Objective

The study seeks to determine if, in comparison to the usual treatment of breast radiation and hormonal therapy, a more conservative
treatment of hormonal therapy alone is as effective in women with low-risk, early-stage, hormone-sensitive breast cancer who have had a lumpectomy. Primary Outcome Measure: Time to invasive or noninvasive IBTR at five years.

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 MammaPrintยฎ 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

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*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)


PROOFS

Overview

Real World Data and long-term follow-up of female pre- and perimenopausal patients with luminal early breast cancer with intermediate to high clinical risk for
recurrence and low genomic recurrence-risk measured by MammaPrintยฎ, treated by standard-of-care endocrine treatment plus ovarian function suppression (OFS) or standard-of-care chemotherapy treatment followed by endocrine treatment.

Trial Primary Objective

The PROOFS Registry study aims to answer the following questions:

  • What is the optimal endocrine therapy for pre- and perimenopausal patients?
  • What impact does ovarian suppression have on long-term survival and quality of life?
  • Can a possible chemotherapy benefit be attributed to chemotherapy-induced amenorrhea?
  • What prognostic significance do clinical and genomic risk factors have?
  • How is therapy adherence?

Study Design

Non-interventional study to evaluate distant recurrence-free survival in all patients treated with (intensified) endocrine therapy alone (without chemotherapy) – and with ovarian suppression in cases with increased clinical risk according to current AGO recommendations.

  • Multicentric
  • Non-interventional
  • Prospective