Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

725

Participants

Timeline

Start Date

November 15, 2025

Primary Completion Date

November 15, 2037

Study Completion Date

December 30, 2037

Conditions
Breast NeoplasmsCarcinoma, Ductal, BreastReceptors, Estrogen (for ER-positive Requirement)
Interventions
DEVICE

ctDNA-Guided Treatment Strategy

Circulating tumor DNA testing using Signatera Genome assay is performed every 3 months for up to 4 years to guide timing of CDK4/6 inhibitor initiation. Participants with positive ctDNA results initiate CDK4/6 inhibitor therapy (ribociclib or abemaciclib) plus standard endocrine therapy for a minimum of 2 years. Participants with negative ctDNA results continue endocrine therapy alone with ongoing surveillance. CDK4/6 inhibitor selection and endocrine therapy regimen per the physician's choice following standard-of-care guidelines.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Natera, Inc.

INDUSTRY

NCT07214532 - Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer | Biotech Hunter | Biotech Hunter