Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (NCT07214532)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (9 items).
Location: Mayo Clinic Arizona — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient has had prior exposure to a CDK4/6 inhibitor.
- Patient is concurrently using hormone replacement therapy.
- Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.
- Patients with a multicentric and/or multifocal and synchronous contralateral breast cancer are ineligible.
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment.
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years.
- Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (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
💰 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.