Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Public ClinicalTrials.gov record NCT07214532. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SIgnatera-Guided Initiation of Adjuvant CDK4/6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07214532
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 725 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 7, 2026
- Primary completion
- May 14, 2032
- Completion
- Dec 29, 2037
- Last update posted
- Aug 31, 2026
2026 – 2037
United States locations
- U.S. sites
- 49
- U.S. states
- 26
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | Not yet recruiting |
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | Not yet recruiting |
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | Not yet recruiting |
| Marin Cancer Care | Greenbrae | California | 94904 | Not yet recruiting |
| Loma Linda University | Loma Linda | California | 92354 | Not yet recruiting |
| Cancer and Blood Research Center | Los Alamitos | California | 90720 | Not yet recruiting |
| UCLA David Geffen School of Medicine | Santa Monica | California | 90404 | Not yet recruiting |
| Stockton Hematology Oncology Medical Group | Stockton | California | 95204 | Recruiting |
| Kaiser Permanente NorCal | Vallejo | California | 94589 | Not yet recruiting |
| Intermountain Health | Grand Junction | Colorado | 81501 | Not yet recruiting |
| Hartford Healthcare Institute | Hartford | Connecticut | 06102 | Not yet recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06520 | Not yet recruiting |
| Baptist MD Anderson | Jacksonville | Florida | 32207 | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Not yet recruiting |
| Jupiter Medical Cancer | Jupiter | Florida | 33458 | Recruiting |
| Werheim Cancer Institute | Miami | Florida | 33176 | Not yet recruiting |
| Ocala Oncology | Ocala | Florida | 34474 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Not yet recruiting |
| Northwest Cancer Center | Dyer | Indiana | 46311 | Recruiting |
| Indiana University | Indianapolis | Indiana | 46202 | Not yet recruiting |
| Willis Knighton Cancer Center | Shreveport | Louisiana | 71103 | Not yet recruiting |
| New England Cancer Specialists | Westbrook | Maine | 04092 | Not yet recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Not yet recruiting |
| Karmanos Cancer Center - Wayne State University | Detroit | Michigan | 48201 | Not yet recruiting |
| Cancer & Hematology Centers | Grand Rapids | Michigan | 49504 | Not yet recruiting |
| Munson Medical Center Cowell Family Cancer Center | Traverse City | Michigan | 49684 | Not yet recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Not yet recruiting |
| Mercy Health - Sindelar Cancer Center | St Louis | Missouri | 63128 | Not yet recruiting |
| Mercy Health - Pratt Cancer Center | St Louis | Missouri | 63141 | Not yet recruiting |
| Cooper Health | Camden | New Jersey | 08103 | Not yet recruiting |
| Rutgers | New Brunswick | New Jersey | 08901 | Not yet recruiting |
| New Mexico Oncology & Hematology Consultants | Albuquerque | New Mexico | 87109 | Not yet recruiting |
| New York Cancer and Blood Specialists | Babylon | New York | 11702 | Recruiting |
| NYU Langone Health | New York | New York | 10016 | Not yet recruiting |
| University of Rochester (URMC) | Rochester | New York | 14642 | Not yet recruiting |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | Not yet recruiting |
| Atrium Levine Cancer Institute | Charlotte | North Carolina | 28204 | Not yet recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Not yet recruiting |
| Allegheny (AHN) | Pittsburgh | Pennsylvania | 15212 | Not yet recruiting |
| Sanford Health | Sioux Falls | South Dakota | 57104 | Not yet recruiting |
| West Cancer Center | Germantown | Tennessee | 38138 | Not yet recruiting |
| Vanderbilt | Nashville | Tennessee | 37232 | Not yet recruiting |
| Houston Methodist Hospital | Houston | Texas | 77030 | Not yet recruiting |
| Inova | Fairfax | Virginia | 33021 | Not yet recruiting |
| Northwest Medical Specialties, PLLC | Puyallup | Washington | 98373 | Recruiting |
| Fred Hutch Cancer Center | Seattle | Washington | 98109 | Not yet recruiting |
| MultiCare Cancer Institute | Tacoma | Washington | 98405 | Recruiting |
| West Virginia University | Morgantown | West Virginia | 26506 | Not yet recruiting |
| University of Wisconsin | Madison | Wisconsin | 53792 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07214532, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 31, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07214532 live on ClinicalTrials.gov.