Alliance Foundation Trials and Natera Announce AFT-70 NAVIGATE: a Global, Randomized, Phase III Trial Evaluating Genentech’s Oral Selective Estrogen Receptor Degrader (SERD) with Signatera™ MRD-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Key Highlights
- ➤AFT launches global randomized phase III NAVIGATE trial for intermediate- and high-risk breast cancer
- ➤More than 2,000 patients expected across approximately 200 U.S. and international sites
- ➤Investigational arm uses giredestrant monotherapy with CDK4/6 inhibitors added after Signatera MRD positivity
- ➤Control arm combines standard endocrine therapy with upfront CDK4/6 inhibition
- ➤Primary endpoint is non-inferiority in 4-year distant recurrence-free survival
Expert Statements
Evanthia Galanis, President of Alliance Foundation Trials, LLC
“This collaboration brings together leading expertise in breast cancer research, clinical care, and molecular testing to address an important question for patients: How can we make treatment more precise while avoiding unnecessary toxicity?”
Evanthia Galanis, President of Alliance Foundation Trials, LLC
“By using MRD technology to guide treatment decisions, this trial has the potential to transform care for eligible breast cancer patients and individualize treatment intensity.”
Komal Jhaveri, Study chair, breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center
“We know that patients with ER-positive, HER2-negative breast cancer do not all face the same risk of recurrence, yet adjuvant treatment decisions are still largely based on clinical and pathological features measured at diagnosis.”
Komal Jhaveri, Study chair, breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center
“The AFT-70 NAVIGATE trial combines two important advances: an endocrine therapy backbone with giredestrant and longitudinal MRD testing with Signatera that can provide a dynamic measure of recurrence risk.”
Komal Jhaveri, Study chair, breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center
“The trial will determine whether MRD-guided monitoring can distinguish patients most likely to benefit from adding a CDK4/6 inhibitor from those in whom it can be safely omitted.”
Komal Jhaveri, Study chair, breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center
“It’s an important step forward using biology—not just baseline risk—to guide adjuvant therapy.”
Gaorav Gupta, Study co-chair, breast radiation oncologist, and co-leader of the Breast Cancer Research Program at UNC Lineberger Comprehensive Cancer Center
“More treatment is not always better treatment.”
Gaorav Gupta, Study co-chair, breast radiation oncologist, and co-leader of the Breast Cancer Research Program at UNC Lineberger Comprehensive Cancer Center
“CDK4/6 inhibitors can be an important part of care for some patients, but they can also add side effects, monitoring, and treatment burden.”
Gaorav Gupta, Study co-chair, breast radiation oncologist, and co-leader of the Breast Cancer Research Program at UNC Lineberger Comprehensive Cancer Center
“If highly sensitive blood-based MRD testing can identify patients who can safely defer additional therapy, we may be able to spare many patients from the burdens of more treatment while maintaining excellent cancer control.”
Gaorav Gupta, Study co-chair, breast radiation oncologist, and co-leader of the Breast Cancer Research Program at UNC Lineberger Comprehensive Cancer Center
“That is the promise we hope to explore through this study.”
Minetta Liu, Chief medical officer, oncology and early cancer detection, Natera
“Natera and AFT have a longstanding partnership and shared commitment to cutting-edge trials across many cancer types.”
Minetta Liu, Chief medical officer, oncology and early cancer detection, Natera
“AFT-70 NAVIGATE creates enormous potential to enhance treatment options for patients with intermediate and high-risk, hormone receptor positive breast cancer.”
Alliance Foundation Trials and Natera Announce AFT-70 NAVIGATE: a Global, Randomized, Phase III Trial Evaluating Genentech’s Oral Selective Estrogen Receptor Degrader (SERD) with Signatera™ MRD-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Trial will use Natera’s ultrasensitive MRD test, Signatera Genome with Phased and Structural Variants, paired with giredestrant monotherapy, Genentech’s investigational oral SERD, aiming to spare patients unnecessary CDK4/6 inhibitor exposure and associated toxicities
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