Condition: Breast Neoplasms · Carcinoma, Ductal, Breast · Receptors, Estrogen (for ER-positive Requirement) · Sponsor: Natera, Inc.
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.
This description comes directly from the study's public registry record.
Kayla Gelow, MS · 844-778-4700 · kgelow@natera.com
Jessica Reyes, BS · 844-778-4700 · jguilford@natera.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Not Yet Recruiting |
| Mayo Clinic Arizona | Phoenix, Arizona, United States | Not Yet Recruiting |
| Honor Health Research Institute | Scottsdale, Arizona, United States | Not Yet Recruiting |
| University of Arizona Cancer Center | Tucson, Arizona, United States | Not Yet Recruiting |
| Adventist Health/AIS Cancer Center | Bakersfield, California, United States | Not Yet Recruiting |
| Marin Cancer Care | Greenbrae, California, United States | Not Yet Recruiting |
| Loma Linda University | Loma Linda, California, United States | Not Yet Recruiting |
| UCLA David Geffen School of Medicine | Santa Monica, California, United States | Not Yet Recruiting |
| Stockton Hematology Oncology Medical Group | Stockton, California, United States | Recruiting |
| Kaiser Permanente NorCal | Vallejo, California, United States | Not Yet Recruiting |
| Hartford Healthcare Institute | Hartford, Connecticut, United States | Not Yet Recruiting |
| Yale Cancer Center | New Haven, Connecticut, United States | Not Yet Recruiting |
+ 27 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07214532