Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
NCT: NCT07214532 · RECRUITING
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with intermediate-risk HR+/HER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4/6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments.
Frequently Asked Questions
What is Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer?
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer is a clinical trial registered under NCT07214532. Current status: RECRUITING.
What is the status of NCT07214532?
The current status of NCT07214532 (Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer) is: RECRUITING.
When did Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer start?
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer started on 2026-03-24.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.