ECOG-ACRIN and Caris Life Sciences partner to interrogate landmark TAILORx breast cancer trial

The first project under a new multi-year research collaboration is the interrogation of the TAILORx breast cancer trial, enabling discovery for risk stratification, prediction of recurrence and racial disparity drivers

ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and Caris Life Sciences^®(Caris) announced a multi-year research collaboration wherein Caris is pairing its highly sophisticated and comprehensive genomic, transcriptomic and proteomic profiling, advanced artificial intelligence (AI) and machine learning algorithms with ECOG-ACRIN’s immense research capabilities.

The first project is underway and leverages the tumor tissue samples from the Trial Assigning Individualized Options for Treatment (Rx) or TAILORx, breast cancer clinical trial. TAILORx is one of the world’s largest breast cancer research resources. The TAILORx trial and its associated biospecimen collections and biobanking was supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and the trial was designed and led by ECOG-ACRIN Group with participation of all the NCI Cooperative Groups

The TAILORx project will explore early-stage breast cancer, where the risk of recurrence is a primary concern for many people. According to the American Cancer Society, breast cancer remains the most common cancer overall, with approximately 310,720 new cases in the United States annually. Approximately 60% of these new cases are in the early stage (no spread to surrounding lymph nodes).

While there has been an overall 42% decline in breast cancer deaths over the last 30 years—due to increased use of mammograms, earlier diagnoses, and more effective treatments—there is a persistent mortality gap between minority patients and white patients.

A TAILORx analysis published in JAMA Surgery is the first to show that racial and ethnic differences in locoregional breast cancer recurrence patterns are prevalent even in a clinical trial population with similar access to care.

“Our collaboration with Caris has deep roots, aligned interests, and a commitment to develop the best science in the service of early detection and treatment of cancer.

The promise of the joint effort is to provide broad availability of cutting-edge options for cancer patients in their communities,” – said Peter J. O’Dwyer, Group Co-Chair of ECOG-ACRIN.

“I’m excited to build on the trial’s initial findings which prevented millions of women with early breast cancer from having to endure toxic treatments, to continue discerning valuable insights related to long term recurrence risk and to identify even more women who may benefit from more efficient treatment options.

It is truly a full circle moment for me, as I’ve been involved with this landmark biomarker trial–the largest ever sponsored by the NCI–during trial development, patient enrollment, findings reporting and now the next phase of research of TAILORx with Caris,” – said George W. Sledge, Jr., EVP and Chief Medical Officer of Caris.

As part of the project, Caris will perform comprehensive molecular characterization (whole exome and transcriptome sequencing) on tumor tissues contributed by nearly 10,000 patients with early-stage breast cancer who participated in the TAILORx trial.

Participants have been followed for 11 years or more, with planned follow-up for 20 years. Caris will couple its molecular testing with its advanced AI and machine learning algorithms. Data from the project will also be made publicly available after a designated time-period following completion of the research project plan in an appropriate NCI database.

“Given the innovative capabilities offered by Caris, analysis of TAILORx biospecimens with cutting-edge AI approaches provides a great opportunity to discover superior biomarkers for risk stratification, prediction of recurrence and better understanding of racial disparities.

The size and impact of TAILORx makes it a perfect study to lead off this collaboration,” – said Mitchell D. Schnall, Group Co-Chair of ECOG-ARIN.

 

Additionally, ECOG-ACRIN joined the Caris Precision Oncology Alliance™ (Caris POA), a global network of leading cancer centers and research consortia that collaborate to advance precision oncology and biomarker-driven research, with its members working together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients.

“Our shared vision of improving the outcomes of all patients with cancer will nurture this collaborative effort with the ECOG-ACRIN researchers. We aim to achieve common goals in advancing precision medicine and biomarker research in cancer, and to increase treatment options for cancer patients,” – said Sledge of ECOG-ACRIN joining the Caris POA.

About ECOG-ACRIN

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is an expansive membership-based scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer. The Group comprises nearly 1400 member institutions and 21,000 research professionals in the United States and around the world.

ECOG-ACRIN is known for advancing precision medicine and biomarker research through its leadership of major national clinical trials, including TAILORx, NCI-MATCH, ComboMATCH, and many others, that integrate cutting-edge genomic approaches. Member researchers and advocates collaborate across more than 40 scientific committees to design studies spanning the cancer care spectrum, from early detection to management of advanced disease. ECOG-ACRIN is funded primarily by the National Cancer Institute, part of the National Institutes of Health. Visit ecog-acrin.org, and follow us on X @eaonc, Facebook, LinkedIn, Instagram, and YouTube.

About Caris Life Sciences

Caris Life Sciences^® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multi-modal database and computing capability needed to analyze and unravel the molecular complexity of disease.

This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development.

Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition, and we value our employees as much as we do our patients of every creed, color, sex, sexual orientation and religion. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets.

About TAILORx

The groundbreaking TAILORx trial provided an evidence-based answer to the question of which patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early-stage breast cancer (no spread to the surrounding lymph nodes) may forego chemotherapy following surgery.

The trial found that chemotherapy may be avoided in patients with this type of breast cancer and a score of 0-25 on the Oncotype DX Breast Recurrence Score™ test who are postmenopausal or older than 50 at diagnosis, and also in most patients with this type of breast cancer who are younger than 50 or premenopausal (Sparano JA et al. N Engl J Med. 2018). With longer follow-up (12 years of survival and recurrence outcomes), the main study findings remain unchanged.

One critically important aspect of TAILORx was the development of the biorepository for future research. TAILORx was funded by the National Cancer Institute, part of the National Institutes of Health, and supported in part by the Breast Cancer Research Foundation, Susan G. Komen, and the Breast Cancer Research Stamp.

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