Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

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 r

Trial Details

NCT ID
NCT07214532
Phase
NA
Sponsor
Natera, Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • ctDNA-Guided Treatment Strategy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Bakersfield, California, United States|35.37329,-119.01871

Key Eligibility Criteria

  • Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.
  • Patient is ≥ 18 years-old at the time of ICF signature.
  • Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.
  • Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemothera…

For full eligibility, visit ClinicalTrials.gov.

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