The purpose of this study is to determine how circulating tumor DNA (ctDNA), a sign of minimal residual disease (MRD), is detectable after surgery in patients with early HR+/HER2- breast cancer that has spread to 1-3 lymph nodes. Researchers aim to understand if ctDNA detection can identify patients at higher risk of recurrence and guide better treatment decisions. A key aspect is the inclusion of a dedicated cohort of African American/Black women, a group underrepresented in molecular residual disease (MRD) research despite experiencing more aggressive breast cancers. This study will correlate ctDNA results with treatment patterns (radiotherapy, systemic therapy) and outcomes (recurrence-free and overall survival) in both non-African American and African American participants.
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
Age ≥ 18 years at time of consent.
Subject must have had surgical intervention and must have sufficient archival specimens from either the primary tumor or a lymph node for ctDNA assay development, as specified in the lab manual.
Subjects must not have had prior neoadjuvant therapy.
Evidence of metastatic disease in imaging.
N1 mic or isolated tumor cells in the lymph nodes
Parallel
Circulating tumor DNA
Diagnostic testCirculating tumor DNA (ctDNA) is a noninvasive prognostic biomarker for disease monitoring. ). Blood collection for ctDNA testing will be performed at the time of enrollment (prior to initiation of adjuvant therapy), and every three months thereafter.
Number of participants have post-operative circulating tumor DNA (ctDNA) positive
Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. Post-operative ctDNA status will be categorized as either detectable or undetectable.
Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 1
Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. ctDNA status will be categorized as either detectable or undetectable in Cohort1.
Number of participants have circulating tumor DNA (ctDNA) positive in Cohort 2
Circulating tumor DNA (ctDNA) will be tested and a number of participants who were tested for positive ctDNA status. ctDNA status will be categorized as either detectable or undetectable in Cohort2.
Number of participants have circulating tumor DNA (ctDNA) positive at 12 months
Circulating tumor DNA (ctDNA) will be tested at 12 month and a number of participants who were tested for positive ctDNA status. ctDNA status will be categorized as either detectable or undetectable at 12 months from the time of surgery, vs otherwise in cohorts 1 and 2.
ctDNA clearance after systemic adjuvant chemotherapy in cohorts 1 and 2
ctDNA clearance after systemic adjuvant chemotherapy in cohorts 1 and 2 participants with ctDNA positivity post-operatively will be defined as the proportion of participants who convert from ctDNA positive to negative after completion of adjuvant chemotherapy if indicated.
ctDNA clearance after adjuvant radiation therapy in cohorts 1 and 2
ctDNA clearance after adjuvant radiation therapy in cohorts 1 and 2 participants with ctDNA positivity post-operatively will be defined as the proportion of participants who convert from ctDNA positive to negative after completion of adjuvant radiation therapy, if indicated.
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
Haystack Oncology, Inc.
Collaborator
