SIgnatera-Guided Initiation of Adjuvant CDK4/6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer
Natera, Inc.
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. 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.
Description
Participants with intermediate-risk, early-stage HR+/HER2- breast cancer will be enrolled in a prospective, single-arm, multicenter phase II study. Circulating tumor DNA (ctDNA) surveillance will be performed using the Signater Genome assay, which is customized for each participant from archived tumor and matched normal DNA to detect up to 64 tumor-specific variants in plasma. Participants who are ctDNA positive at baseline will start CDK4/6 inhibitor therapy along with hormone therapy. Those who are ctDNA negative will continue hormone therapy with ctDNA testing every three months. If ctDNA…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure. 2. Patient is ≥ 18 years-old at the time of ICF signature. 3. Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male. 4. Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemotherapy, if indicated, or within 6 months of initiating adjuvant endocrine therapy if chemotherapy is not indicated. Patients who receive neoadjuvan…
Interventions
- DevicectDNA-Guided Treatment Strategy
Circulating tumor DNA testing using Signatera Genome assay is performed every 3 months for up to 4 years to guide timing of CDK4/6 inhibitor initiation. Participants with positive ctDNA results initiate CDK4/6 inhibitor therapy (ribociclib or abemaciclib) plus standard endocrine therapy for a minimum of 2 years. Participants with negative ctDNA results continue endocrine therapy alone with ongoing surveillance. CDK4/6 inhibitor selection and endocrine therapy regimen per the physician's choice following standard-of-care guidelines.
Locations (39)
- University of Alabama at BirminghamBirmingham, Alabama
- Mayo Clinic ArizonaPhoenix, Arizona
- Honor Health Research InstituteScottsdale, Arizona
- University of Arizona Cancer CenterTucson, Arizona
- Adventist Health/AIS Cancer CenterBakersfield, California
- Marin Cancer CareGreenbrae, California