Clinical trialNCT07214532RecruitingInterventional

Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

SponsorNatera, Inc.Enrollment725Breast NeoplasmsCarcinoma, Ductal, BreastReceptors, Estrogen (for ER-positive Requirement)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Angel Rodriguez, MD
Natera, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

48 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Mayo Clinic Arizona
Phoenix, Arizona, United States
Shakeela Bahadur, MD
Not, yet, recruiting
Honor Health Research Institute
Scottsdale, Arizona, United States
Abhimanyu Ghose, MDWishwdeep Dhillon, MD
Not, yet, recruiting
University of Arizona Cancer Center
Tucson, Arizona, United States
Sima Ehsani, MD
Not, yet, recruiting
Marin Cancer Care
Greenbrae, California, United States
Cyrus Mazidi, MD
Not, yet, recruiting
Loma Linda University
Loma Linda, California, United States
Gayathri Nagaraj, MD
Not, yet, recruiting
Cancer and Blood Research Center
Los Alamitos, California, United States
John Wong
Not, yet, recruiting
Ucla David Geffen School of Medicine
Santa Monica, California, United States
Marla Lipsyc-Sharf, MD
Not, yet, recruiting
Stockton Hematology Oncology Medical Group
Stockton, California, United States
Ajithkumar Puthillath, MD
Recruiting
Kaiser Permanente Norcal
Vallejo, California, United States
Jennifer Suga, MD
Not, yet, recruiting
Intermountain Health
Grand Junction, Colorado, United States
Alicia Swink
Not, yet, recruiting
Hartford Healthcare Institute
Hartford, Connecticut, United States
Richard Zelkowitz, MD
Not, yet, recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Lajos Pusztai, MD
Not, yet, recruiting
Baptist Md Anderson
Jacksonville, Florida, United States
Dayra Avila-Lima, MD
Recruiting
Mayo Clinic Florida
Jacksonville, Florida, United States
Pooja Advani, MD
Not, yet, recruiting
Jupiter Medical Cancer
Jupiter, Florida, United States
Danielle Krol, MD
Recruiting
Werheim Cancer Institute
Miami, Florida, United States
Reshma Mahtani, DO
Not, yet, recruiting
Ocala Oncology
Ocala, Florida, United States
Rama Balaraman, MD
Recruiting
Northwestern University
Chicago, Illinois, United States
William Gradishar, MD
Not, yet, recruiting
Northwest Cancer Center
Dyer, Indiana, United States
Shruti Singh, MD
Recruiting
Indiana University
Indianapolis, Indiana, United States
Bryan Schneider
Not, yet, recruiting
New England Cancer Specialists
Westbrook, Maine, United States
Chiara Battelli, MD
Not, yet, recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Arielle Medford
Not, yet, recruiting
Karmanos Cancer Center - Wayne State University
Detroit, Michigan, United States
Jailan Elayoubi
Not, yet, recruiting
Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Haritha Reddy
Not, yet, recruiting
Munson Medical Center Cowell Family Cancer Center
Traverse City, Michigan, United States
Yelena Kier, DO
Not, yet, recruiting
Mayo Clinic
Rochester, Minnesota, United States
Karthik Giridhar, MD
Not, yet, recruiting
Mercy Health - Pratt Cancer Center
St Louis, Missouri, United States
Bethany Sleckman, MD
Not, yet, recruiting
Mercy Health - Sindelar Cancer Center
St Louis, Missouri, United States
Yifan Tu, MD
Not, yet, recruiting
Cooper Health
Camden, New Jersey, United States
Kamel Abou-Hussein, MD
Not, yet, recruiting
Rutgers
New Brunswick, New Jersey, United States
Mridula George, MD
Not, yet, recruiting
New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico, United States
Katherine Sanchez
Not, yet, recruiting
New York Cancer and Blood Specialists
Babylon, New York, United States
Richard Zuniga
Recruiting
Nyu Langone Health
New York, New York, United States
Nancy Chan
Not, yet, recruiting
University of Rochester (urmc)
Rochester, New York, United States
Susan Dent
Not, yet, recruiting
Stony Brook Cancer Center
Stony Brook, New York, United States
Alison Stopeck
Not, yet, recruiting
Atrium Levine Cancer Institute
Charlotte, North Carolina, United States
Arielle Heeke, MD
Not, yet, recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Azka Ali
Not, yet, recruiting
Allegheny (ahn)
Pittsburgh, Pennsylvania, United States
Joseph Liput, MD
Not, yet, recruiting
Sanford Health
Sioux Falls, South Dakota, United States
Allison Watson, MD
Not, yet, recruiting
West Cancer Center
Germantown, Tennessee, United States
Gary Tian, MD
Not, yet, recruiting

8 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 May 2026
Primary completion: 15 Nov 2037
Completion: 30 Dec 2037
Last update posted: 13 Aug 2026
Registered enrollment: 725
Registry id: NCT07214532

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.