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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: Recruiting NA study, sponsored by Natera.
NCT07214532 is a NA study that is actively recruiting participants, run by Natera. The registered enrollment target is 725 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
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 |
What NCT07214532 shows while recruiting
NCT07214532 is an interventional study that assigns participants to a tested intervention. The registered 725 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which ctDNA-Guided Treatment Strategy is the first listed.
NCT07214532 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07214532's enrollment target sits among peer trials
725 145th of 2000 higher than 1,856 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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