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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 725 participants |
| Start Date | 2026-03-24 |
| Est. Completion | 2037-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗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.
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