Komal Jhaveri, Section Head and Endocrine Therapy, Breast Medicine Service at Memorial Sloan Kettering Cancer Center, shared on LinkedIn:
“I’m honored to serve as study chair, alongside my co-chair Gaorav Gupta, for AFT-70 NAVIGATE, a phase III trial that asks a question many of us face in clinic every day: who truly needs a CDK4/6 inhibitor, and who can safely be spared?
For patients with intermediate- and high-risk ER+/HER2- early breast cancer, adjuvant CDK4/6 inhibitors improve outcomes, but they also bring real toxicity, cost, and treatment burden, and we currently offer them based on baseline risk alone.
NAVIGATE takes a different approach:
- Patients with no detectable molecular residual disease (MRD) (Signatera) after standard therapy are randomized to standard endocrine therapy + upfront CDK4/6i, or to the novel oral SERD, giredestrant
- In the giredestrant arm, a CDK4/6 inhibitor is added only if MRD becomes detectable during serial monitoring
- Primary endpoint: non-inferior 4-year distant recurrence-free survival
The idea is to treat based on how each patient’s risk changes over time, rather than on a single snapshot at diagnosis. If successful, this could spare many patients from unnecessary therapy while escalating treatment for those who need it, when they need it.
The trial will enroll more than 2,000 patients across ~200 sites in the U.S. and internationally. Heartfelt thanks to our Alliance breast committee chairs, Ann Partridge and Lisa Carey, and to Filipa Lynce and the Alliance Foundation Trials team for their leadership and support; to our partners at Natera and Genentech; and above all to the patients and investigators who make this work possible.”
This also can be interesting:
