Natera Inc. ((NTRA)) announced an update on their ongoing clinical study.
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Natera Inc. has initiated a new clinical study titled ‘Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer.’ The study aims to evaluate the efficacy and safety of using the Signatera Genome test to guide the initiation of CDK4/6 inhibitor therapy in patients with intermediate-risk HR+/HER2- early-stage breast cancer. This approach seeks to optimize treatment timing based on ctDNA test results, potentially reducing unnecessary treatments while maintaining efficacy compared to historical controls.
The intervention being tested is a ctDNA-guided treatment strategy using the Signatera Genome assay. This device-based intervention involves regular ctDNA testing every three months to decide whether participants should begin CDK4/6 inhibitor therapy alongside standard endocrine therapy or continue with endocrine therapy alone.
The study is designed as a single-group, non-randomized trial where all participants undergo ctDNA surveillance. Treatment decisions are based on ctDNA results, with no masking involved. The primary purpose is to evaluate treatment efficacy.
The study is set to start on September 24, 2025, with the primary completion date yet to be determined. The last update was submitted on October 2, 2025. These dates are crucial for tracking the study’s progress and potential market impact.
This study could significantly impact Natera’s stock performance by demonstrating the clinical utility of the Signatera test in guiding breast cancer treatment. If successful, it could enhance investor sentiment and position Natera favorably against competitors in the precision oncology market.
The study is ongoing, with further details available on the ClinicalTrials portal.