The ECOG-ACRIN Cancer Research Group and Caris Life Sciences announced a new multiyear research collaboration that will begin with the interrogation of the TAILORx trial.
Background
Breast cancer remains the most common cancer type in the United States, with approximately 310,720 new cases per year, according to the American Cancer Society. Approximately 60% of these new cases are in the early stage without metastasis to the surrounding lymph nodes. Although there has been a 42% decline overall in breast cancer–related mortality over the past 30 years—as a result of increased use of mammograms, earlier diagnoses, and more effective treatments—there is a persistent mortality gap between White and minority patients. Further, the risk of recurrence is a primary concern for many patients with early-stage breast cancer.
The groundbreaking TAILORx trial revealed which patients with estrogen receptor–positive, HER2-negative early-stage breast cancer may forgo chemotherapy following surgery. Researchers discovered that patients with this subtype of breast cancer who scored a 0 to 25 on the Oncotype DX Breast Recurrence Score and were postmenopausal or older than age 50 at diagnosis as well as those who were younger than age 50 or premenopausal were able to avoid chemotherapy. The main study findings remained unchanged with longer follow-up.
A critical aspect of the TAILORx trial was its associated biorepository—one of the world’s largest breast cancer research resources.
A TAILORx analysis, published in JAMA Surgery, was among the first to show that racial and ethnic differences in locoregional breast cancer recurrence patterns were prevalent, even in a clinical trial population with similar access to care.
Overview of the TAILORx Project
Through the new TAILORx project, investigators will pair comprehensive genomic, transcriptomic, and proteomic profiling as well as advanced artificial intelligence (AI) and machine learning algorithms from Caris Life Sciences with the research capabilities of the ECOG-ACRIN Cancer Research Group. The investigators plan to leverage breast cancer tissue samples from the TAILORx trial to explore early-stage breast cancer.
As part of the project, Caris Life Sciences 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. The participants have been followed for 11 years or more, with planned follow-up for 20 years. Caris Life Sciences will couple its molecular testing with its advanced AI and machine learning algorithms. Data from the project will be made publicly available after a designated period following completion of the research project plan in an appropriate National Cancer Institute (NCI) database.
“I’m excited to build on the trial’s initial findings, which prevented millions of women with early-[stage] 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,” highlighted George W. Sledge, Jr, MD, Executive Vice President and Chief Medical Officer of Caris Life Sciences. “It is truly a full-circle moment for me, as I’ve been involved with this landmark biomarker trial … during trial development, patient enrollment, findings reporting, and now the next phase of research of TAILORx with Caris [Life Sciences],” he detailed.
“Given the innovative capabilities offered by Caris [Life Sciences], 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,” indicated Mitchell D. Schnall, MD, PhD, Group Co-Chair of the ECOG-ARIN Cancer Research Group. “The size and impact of TAILORx make it a perfect study to lead off this collaboration,” he underlined.
Conclusions
“Our collaboration with Caris [Life Sciences] has deep roots, aligned interests, and a commitment to develop the best science in the service of early detection and treatment of cancer,” emphasized Peter J. O’Dwyer, MD, Group Co-Chair of the ECOG-ACRIN Cancer Research Group. “The promise of the joint effort is to provide broad availability of cutting-edge options for [patients with] cancer in their communities,” he continued.
The ECOG-ACRIN Cancer Research Group recently joined the Caris Precision Oncology Alliance, a global network of cancer centers and research consortia designed 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.
“Our shared vision of improving the outcomes of all patients with cancer will nurture this collaborative effort with the ECOG-ACRIN [Cancer Research Group] researchers. We aim to achieve common goals in advancing precision medicine and biomarker research in cancer, and to increase treatment options for patients [with cancer],” concluded Dr. Sledge.
Disclosure: The TAILORx trial was supported by the NCI and in part by the Breast Cancer Research Foundation, Susan G. Komen, and the Breast Cancer Research Stamp.
