Natera launched a Phase III clinical trial.
It partners with Alliance Foundation Trials (AFT) and Genentech.
The trial evaluates a new approach for early-stage breast cancer treatment.
The AFT-70 NAVIGATE trial will use Natera's Signatera blood test.
This test guides therapy for patients with intermediate and high-risk ER-positive/HER2-negative breast cancer.
The study aims to determine if the Signatera molecular residual disease (MRD) test identifies patients.
These patients could safely avoid a CDK4/6 inhibitor drug after standard treatment.
Patients who test negative for residual disease will be randomly assigned.
They will receive either investigational monotherapy giredestrant or the standard of care.
The standard of care includes a CDK4/6 inhibitor.
This MRD-guided strategy could spare patients from the side effects and costs of an additional drug.
The trial plans to enroll over 2,000 patients.
It will operate across approximately 200 global sites.