Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisana i datowana zgoda na uczestnictwo w badaniu, udzielona przed jakimikolwiek procedurami badania.
- •Wiek co najmniej 18 lat w momencie podpisania zgody.
- •Kobieta ze znanym statusem menopauzalnym lub mężczyzna.
- •Potwierdzony histologicznie rak piersi z przerzutami do węzłów chłonnych (stadium II) lub bez przerzutów, ale o znacznym rozmiarze guza i/lub wysokim stopniu złośliwości.
- •Rak piersi dodatni dla receptorów estrogenowych i/lub progesteronowych.
- •Rak piersi bez nadekspresji białka HER2 potwierdzonej badaniami molekularnymi.
- •Dostępna tkanka guza z biopsji do testowania w centralnym laboratorium.
- •Planowanie leczenia hormonalnego przez co najmniej 5 lat i zgodność na stosowanie inhibitorów CDK4/6 tylko po wykryciu DNA nowotworu we krwi.
✗ Disqualifies
- •Wcześniejsze stosowanie inhibitorów CDK4/6.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 8, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (39)
University of Alabama at Birmingham
Birmingham, United States
Mayo Clinic Arizona
Phoenix, United States
Honor Health Research Institute
Scottsdale, United States
University of Arizona Cancer Center
Tucson, United States
Adventist Health/AIS Cancer Center
Bakersfield, United States
Marin Cancer Care
Greenbrae, United States
Loma Linda University
Loma Linda, United States
UCLA David Geffen School of Medicine
Santa Monica, United States
Stockton Hematology Oncology Medical Group
Stockton, United States
Kaiser Permanente NorCal
Vallejo, United States
Hartford Healthcare Institute
Hartford, United States
Yale Cancer Center
New Haven, United States
Baptist MD Anderson
Jacksonville, United States
Mayo Clinic Florida
Jacksonville, United States
Jupiter Medical Cancer
Jupiter, United States
Miami Cancer Institute
Miami, United States
Ocala Oncology
Ocala, United States
Northwestern University
Chicago, United States
Northwest Cancer Center
Dyer, United States
New England Cancer Specialists
Westbrook, United States
Karmanos Cancer Center - Wayne State University
Detroit, United States
Cancer & Hematology Centers
Grand Rapids, United States
Munson Medical Center Cowell Family Cancer Center
Traverse City, United States
Mayo Clinic
Rochester, United States
Mercy Health - Sindelar Cancer Center
St Louis, United States
Mercy Health - Pratt Cancer Center
St Louis, United States
Cooper Health
Camden, United States
Rutgers
New Brunswick, United States
New York Cancer and Blood Specialists
Babylon, United States
Atrium Levine Cancer Institute
Charlotte, United States
Allegheny (AHN)
Pittsburgh, United States
Sanford Health
Sioux Falls, United States
West Cancer Center
Germantown, United States
Vanderbilt
Nashville, United States
Houston Methodist Hospital
Houston, United States
Northwest Medical Specialties, PLLC
Puyallup, United States
Fred Hutch Cancer Center
Seattle, United States
MultiCare Cancer Institute
Tacoma, United States
West Virginia University
Morgantown, United States
Trial contact
Kayla Gelow, MS
Jessica Reyes, BS
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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