AFT-70 - (NAVIGATE)

October 5, 2026: Alliance Foundation Trials (AFT) and Natera (NASDAQ: NTRA) announced the launch of AFT-70 NAVIGATE, a randomized Phase III trial in intermediate- and high-risk ER-positive/HER2-negative early breast cancer, sponsored by AFT with collaboration and co-funding from Natera and Genentech.

The study will evaluate an MRD-guided adjuvant treatment strategy using Natera’s Signatera Genome with phased and structural variants alongside giredestrant monotherapy, with the goal of reducing unnecessary upfront CDK4/6 inhibitor exposure. More than 2,000 stage II-III patients are expected to enroll across about 200 U.S. and international sites.

Patients who are MRD-negative by Signatera after standard-of-care treatment will be randomized to either: (1) standard endocrine therapy plus upfront CDK4/6 inhibition, or (2) giredestrant monotherapy, with CDK4/6 inhibition added only if Signatera later becomes positive. The primary endpoint is non-inferiority in 4-year distant recurrence-free survival.

The release says giredestrant was chosen based on Phase III lidERA results showing statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard endocrine monotherapy in this setting.