Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (NCT07214532)
SIgnatera-Guided Initiation of Adjuvant CDK4/6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- Mayo Clinic Arizona — Phoenix, Arizona
- Honor Health Research Institute — Scottsdale, Arizona
- University of Arizona Cancer Center — Tucson, Arizona
- Marin Cancer Care — Greenbrae, California
- Loma Linda University — Loma Linda, California
- Cancer and Blood Research Center — Los Alamitos, California
- UCLA David Geffen School of Medicine — Santa Monica, California
- Stockton Hematology Oncology Medical Group — Stockton, California
- Kaiser Permanente NorCal — Vallejo, California
- Intermountain Health — Grand Junction, Colorado
- Hartford Healthcare Institute — Hartford, Connecticut
- Yale Cancer Center — New Haven, Connecticut
- Baptist MD Anderson — Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida
- Jupiter Medical Cancer — Jupiter, Florida
- Werheim Cancer Institute — Miami, Florida
- Ocala Oncology — Ocala, Florida
- Northwestern University — Chicago, Illinois
- Northwest Cancer Center — Dyer, Indiana
- Indiana University — Indianapolis, Indiana
- New England Cancer Specialists — Westbrook, Maine
- Massachusetts General Hospital — Boston, Massachusetts
- Karmanos Cancer Center - Wayne State University — Detroit, Michigan
- Cancer & Hematology Centers — Grand Rapids, Michigan
- Munson Medical Center Cowell Family Cancer Center — Traverse City, Michigan
📞 Contact the Study Coordinator
Phone: (706) 726-6935
Email: signaler@natera.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.