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NCT07214532 · ClinicalTrials.gov registry record · NA

Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

A NA study, sponsored by Natera.

Recruiting
Registry status
NA
Development phase
725
Enrollment target

NCT07214532 is a NA study that is actively recruiting participants, run by Natera. The registered enrollment target is 725 participants.

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The verdict

NCT07214532, a NA study, is actively recruiting participants, sponsored by Natera.

RECRUITING
Registry status
NA
Development phase
725 participants
Enrollment target

Study 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.

Interventions

  • DEVICE ctDNA-Guided Treatment Strategy

Trial Details

FieldValue
Enrollment Target 725 participants
Start Date 2026-03-24
Est. Completion 2037-12-30
Phase NA

Sponsor

Natera

27 total trials

What the Registry Record Tells You About NCT07214532

The ClinicalTrials.gov registry entry for NCT07214532 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Natera, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ctDNA-Guided Treatment Strategy is the first listed.

NCT07214532 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07214532 about?

NCT07214532 is a clinical study titled "Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer". 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 res...

What is the current status of trial NCT07214532?

This trial is currently recruiting. It is a NA study. The enrollment target is 725 participants. The study started on 2026-03-24. Estimated completion is 2037-12-30.

What interventions are being tested in trial NCT07214532?

The interventions under investigation include: ctDNA-Guided Treatment Strategy (DEVICE).

Who is sponsoring clinical trial NCT07214532?

This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.