cell-free DNA and precision medicine, has officially announced the launch of the TEODOR trial (ABCSG 61), a groundbreaking phase 2, multicenter, randomized controlled trial aimed at optimizing neoadjuvant treatment for patients with hormone receptor-positive (HR+), HER2-negative breast cancer.
The TEODOR trial, sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG), seeks to evaluate the potential of replacing traditional chemotherapy with endocrine therapy in patients who are Signatera™ ctDNA-negative and respond well to hormonal treatment. The trial aims to enroll up to 250 patients across 15 clinical sites in Austria.
This innovative study builds upon previous findings indicating that Signatera-negative patients at diagnosis who underwent chemotherapy had a recurrence risk of under 5%. TEODOR’s main objective is to reduce the use of preoperative chemotherapy, minimizing associated side effects, by focusing on endocrine therapy as a safer and potentially more effective alternative.
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Following a four-week course of endocrine therapy, patients who remain Signatera-negative and demonstrate favorable endocrine responsiveness (as measured by the Ki-67 proliferation index) will be randomized to continue with either chemotherapy or extended endocrine therapy. The study will assess neoadjuvant therapy response through pathological complete response (pCR) and changes in the preoperative endocrine prognostic index (PEPI). Secondary endpoints include overall survival (OS) and breast cancer recurrence.
Dr. Michael Gnant, principal investigator of the trial and professor of surgery at the Medical University of Vienna, emphasized the importance of the study:
“TEODOR is introduced to test whether we can integrate endocrine responsiveness and ctDNA status into systemic therapy in the neoadjuvant setting. This study represents a vital step toward personalized medicine, leveraging the latest technologies to improve patient care.”
Dr. Angel Rodríguez, Medical Director of Oncology at Natera, also commented on the collaboration:
“With the TEODOR trial, our goal is to safely identify patients who can forgo chemotherapy. We are proud to partner with ABCSG on this important initiative, which has the potential to redefine neoadjuvant therapy in breast cancer.”
The launch of TEODOR marks a significant step forward in advancing personalized, less toxic treatments for early-stage breast cancer.
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