Alliance Foundation Trials (AFT) announced the launch of the randomized Phase III clinical trial AFT-70 NAVIGATE for patients with intermediate- and high-risk early ER-positive/HER2-negative breast cancer. The study will assess whether molecular residual disease (MRD) monitoring can more accurately determine the need to add CDK4/6 inhibitors to adjuvant treatment. News-Medical reports on the trial's launch.
The organizers plan to enroll more than 2,000 patients with stage II–III breast cancer at approximately 200 centers in the United States and other countries. Eligible participants will be patients indicated for endocrine therapy whose Signatera test does not detect MRD after standard treatment — surgery, radiation therapy, and chemotherapy when necessary.
Participants will be randomly assigned to two groups. The control group will receive standard endocrine therapy together with a CDK4/6 inhibitor from the start of treatment. In the experimental group, giredestrant — an investigational oral selective estrogen receptor degrader — will be used without a CDK4/6 inhibitor at the outset. A CDK4/6 inhibitor will be added only when the Signatera result becomes positive.
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The primary endpoint of AFT-70 NAVIGATE will be non-inferior distant recurrence-free survival over four years compared with the strategy of early CDK4/6 inhibitor administration in the control group.
According to AFT, giredestrant was selected as the basis of endocrine therapy for the experimental group in light of the results of the Phase III lidERA study. In that study, the drug demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival compared with standard endocrine monotherapy. The Signatera test will be used for regular MRD monitoring.
AFT is the sponsor and lead organization of the study, while Natera and Genentech, part of the Roche Group, are collaborating on its conduct and co-funding. The trial is intended to determine whether an MRD-guided approach can help avoid additional treatment burden for patients who may not need CDK4/6 inhibitors.
