CDK4/6 Inhibitor Therapy for Breast Cancer
(SIGNAL-ER 101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Angel Rodriguez, MD
Principal Investigator
Natera, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- CDK4/6 Inhibitor Therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants receive circulating tumor DNA (ctDNA) testing using Signatera Genome every 3 months to guide treatment decisions. Participants with positive ctDNA results initiate CDK4/6 inhibitor therapy (ribociclib or abemaciclib) in addition to standard endocrine therapy. Participants with negative ctDNA results continue endocrine therapy alone with ongoing ctDNA surveillance. All participants continue their assigned treatment pathway until disease progression, unacceptable toxicity, or study completion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Natera, Inc.
Lead Sponsor
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