Natera has announced the initiation of the Phase II TEODOR trial of its Signatera test aimed at replacing chemotherapy with endocrine therapy before surgery in certain breast cancer patients.
The multicentre, randomised controlled trial (RCT) focuses on women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer who are responsive to endocrine treatment and test negative with Signatera.
Academic research organisation Austrian Breast & Colorectal Cancer Study Group sponsored the trial, which plans to enrol 250 subjects across 15 Austrian sites.
This trial seeks to assess the endocrine therapy鈥檚 efficacy in comparison to chemotherapy in those who are Signatera-negative, to minimise the use of pre-operative chemotherapy and its associated side effects.
After receiving an endocrine therapy course for four weeks, subjects who remain Signatera-negative and exhibit a favourable response as per the Ki-67 proliferation index measurement are set to be randomised to continue with endocrine therapy or chemotherapy.
The primary goal of the TEODOR trial is the response rate to neoadjuvant therapy, gauged by pathological complete response (pCR) and modified Preoperative Endocrine Prognostic Index (PEPI) score, across endocrine and chemotherapy trial arms.
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By GlobalDataSecondary goals encompass long-term effects such as recurrence of breast cancer and overall survival rates.
Signatera is a custom-built blood test for identifying molecular residual disease (MRD) in the form of circulating tumour DNA.
Natera oncology medical director Angel Rodriguez said: 鈥淲ith the TEODOR trial, our goal is to identify patients who may be able to safely forgo chemotherapy.
鈥淲e are proud to collaborate with ABCSG on this important trial, and we hope this study will support the role of Signatera in guiding neoadjuvant therapy in breast cancer.鈥�
The test is covered by Medicare for those with stage IIb and higher breast cancer.
In May 2025, Natera announced outcomes from a study assessing the Signatera MRD test in those with soft tissue and bone sarcomas.
