Signatera-Guided Therapy for Early Breast Cancer

This study is looking at a new way to decide when to start certain breast cancer treatments. If you have early-stage, HR-positive (hormone receptor-positive), HER2-negative breast cancer, you might be able to join. The study uses a blood test called Signatera to look for tiny pieces of cancer DNA (ctDNA). If ctDNA is found, you would start taking a CDK4/6 inhibitor medicine like ribociclib or abemaciclib, along with your usual hormone therapy. If no ctDNA is found, you'll continue hormone therapy and have regular ctDNA tests. The main goal is to see if this ctDNA-guided approach can help you stay cancer-free longer, up to 9 years, compared to past studies.

Study design
This is a single-arm study, meaning all participants receive the same type of intervention, with a planned enrollment of 725 people. It's a Phase II study, which typically focuses on how well a new treatment works and its safety.
What's involved
You would have blood tests every 3 months for up to 4 years to check for ctDNA. You would also receive hormone therapy, and potentially a CDK4/6 inhibitor, with imaging and quality-of-life assessments as needed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 9 years to assess how long they remain free of invasive disease.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214532

Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

Recruiting
NAAges 18+InterventionalTreatment
Natera, Inc.
~725 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:ctDNA-Guided Treatment Strategy

At a glance

Recruiting sites
8 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Invasive Disease-Free Survival
Measured over From the date of surgery up to 9 years
Breast Neoplasms
Carcinoma, Ductal, Breast
Receptors, Estrogen (for ER-positive Requirement)
48 sites across 25 states
California6
Florida5
New York4
Arizona3
Michigan3
Washington3
Connecticut2
Indiana2
  • Angel Rodriguez, MD · STUDY_DIRECTOR · Natera, Inc.

Opens a ready-to-send draft in your own email app — review before sending.

  • Invasive Disease-Free SurvivalFrom the date of surgery up to 9 years

    The primary objective of this study is to to evaluate disease free survival (iDFS) in patients with intermediate risk breast cancer receiving standard endocrine therapy with the addition of CDK4/6 inhibitor therapy upon positive ctDNA test results as compared to historical data of treated patients (NataLEE).