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Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

NCT07214532

This study is recruiting at 11 US sites in 7 states, according to its ClinicalTrials.gov record last updated .

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Breast Neoplasms
  • Carcinoma, Ductal, Breast
  • Receptors, Estrogen (for ER-positive Requirement)

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Natera, Inc.
Last updated on ClinicalTrials.gov
September 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • Marin Cancer Care · Greenbrae, CA
  • Stockton Hematology Oncology Medical Group · Stockton, CA

Florida · 3

  • Baptist MD Anderson · Jacksonville, FL
  • Jupiter Medical Cancer · Jupiter, FL
  • Ocala Oncology · Ocala, FL

Indiana · 1

  • Northwest Cancer Center · Dyer, IN

Michigan · 1

  • Munson Medical Center Cowell Family Cancer Center · Traverse City, MI

New York · 1

  • New York Cancer and Blood Specialists · Babylon, NY

Washington · 2

  • Northwest Medical Specialties, PLLC · Puyallup, WA
  • MultiCare Cancer Institute · Tacoma, WA

West Virginia · 1

  • West Virginia University · Morgantown, WV

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.