AFT and Natera launch NAVIGATE phase III trial of MRD-guided breast cancer treatment
Published in Drugs development & discovery, Personalized medicine, Tools.
On October 5, 2026, Alliance Foundation Trials and Natera announced AFT-70 NAVIGATE, a randomized phase III study of molecular residual disease (MRD)-guided treatment in intermediate- and high-risk ER-positive/HER2-negative early breast cancer. AFT sponsors and leads the trial, with collaboration and co-funding from Natera and Genentech.
The planned study will enroll more than 2,000 patients with stage II–III disease at approximately 200 sites. Participants without detectable MRD after standard treatment will be randomized to standard endocrine therapy plus upfront CDK4/6 inhibition, or investigational giredestrant monotherapy with a CDK4/6 inhibitor added only if Signatera Genome becomes positive.
The primary endpoint is non-inferiority in four-year distant recurrence-free survival. The trial asks whether blood-based monitoring can reduce unnecessary exposure to additional therapy while maintaining cancer outcomes.
This announcement describes a trial launch, not evidence that MRD-guided treatment is already safe or equally effective. Those questions require the randomized clinical results.
Source: Natera and AFT announcement, October 5, 2026.