Natera Launches TEODOR Trial to Personalize Breast Cancer Treatment Without Chemotherapy

Natera Introduces ABCSG 61’s TEODOR Trial

Announcement

Natera Inc., a well-known leader in cell-free DNA and precision medicine, has begun a new TEODOR trial, a neoadjuvant treatment optimization featured by ctDNA and endocrine responsiveness. The TEODOR is a phase 2 multicenter, randomized controlled trial (RCT) that mainly focuses on replacing chemotherapy with endocrine therapy, primarily with surgery, for a woman population with hormone receptor-positive (HR+), HER2-negative based cancer who responds to endocrine therapy and tests negative with signatera. The partnership between the two organizations is progressing well in the field of drug development.

TEODOR’s Prediction and Contribution

TEODOR is sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG). TEODOR tends to enroll a maximum of 250 patients through 15 sites in Austria. The previous studies showcased that the patients who were found to be signatera-negative at diagnosis and later received chemotherapy witnessed remarkable outcomes, with a risk of less than 5%. The efforts of this study are to diminish pre-operative chemotherapy events, which have severe side effects. For which the study is initiated to evaluate the efficacy and safety of endocrine therapy in comparison to chemotherapy in signatera-negative patients.

After the completion of a four-week course of endocrine therapy, the signatera-negative patients who reacted favorably to endocrine sensitivity as analyzed by the Ki-67 proliferation index will be selected to receive either chemotherapy or additional endocrine therapy. This study concludes that the volume of neoadjuvant therapy responses, assessed through pathological complete response (PCR), modifies preoperative endocrine prognostic index (PEPI) rate through the chemotherapy and endocrine therapy arms of the trial. The secondary conclusion to this study consists of long-term outcomes like overall survival (OS) and breast cancer recurrence.

Views and Statements

ABCSG, MD, FACS, FEBS, professor of surgery, Comprehensive Cancer Center, Medical University of Vienna, and principal investigator of the TEODOR trial, Michael Gnant, said, “TEODOR is introduced to test whether we can integrate endocrine responsiveness and ctDNA status to systemic therapy in the neoadjuvant setting. This study symbolizes the vital step into personalized medicine, further accelerating the newest technologies to enhance patient care.”

MD, medical director of oncology at Natera, Angel Rodríguez, said, “along with the TEODOR trial, our motive is to address patients who are undergoing treatment safely through forgo chemotherapy. We are delighted with this partnership with ABCSG on this crucial trial. We hope this study will contribute to the significance of leading neoadjuvant therapy in breast cancer.”