Molecular Residual Disease Assessment to Determine Care for Patients with Early-Stage Breast Cancer

PRIMARY OBJECTIVE:

I. To evaluate the prevalence of ctDNA-based MRD status in cohorts 1 & 2 combined by defining the proportion of patients with MRD-only recurrence post-operatively.

SECONDARY OBJECTIVES:

I. To evaluate the prevalence of ctDNA-based MRD status in cohort 1 participants by defining the proportion of patients with MRD-only recurrence post-operatively.

II. To evaluate the prevalence of ctDNA-based MRD status in Black patients with breast cancer (cohort 2 participants) by defining the proportion of patients with MRD-only recurrence post-operatively.

III. To evaluate the prevalence of ctDNA-based MRD status in cohort 1 and cohort 2 participants by defining the proportion of patients with MRD-only recurrence at 12 months of follow-up.

IV. To assess ctDNA clearance after systemic adjuvant chemotherapy in cohort 1 and cohort 2 patients with ctDNA positivity post-operatively.

V. To assess ctDNA clearance after adjuvant radiation therapy in cohort 1 and 2 patients with ctDNA positivity post-operatively.

VI. To assess ctDNA as a marker for disease recurrence by evaluating recurrence free survival (RFS) in cohort 1 and cohort 2 participants.

VII. To assess ctDNA as a marker for poor survival by evaluating overall survival (OS) in cohort 1 and cohort 2 participants.

EXPLORATORY OBJECTIVES:

I. To assess how ctDNA results impact patterns of care with regard to standard of care (SOC) imaging for staging.

II. To assess how ctDNA results impact patterns of care with regard to SOC axillary radiotherapy.

III. To assess how ctDNA results impact patterns of care with regard to additional SOC systemic therapy.

IV. To correlate ctDNA status with clinical, pathological, and/or genomic risk features in both cohorts 1 & 2.

V. To evaluate genomic and immune predictors of MRD and recurrence.

OUTLINE:

Patients undergo MRD assessment at screening, prior to adjuvant therapy and at 3, 6, 9 and 12 months. Results may be communicated to the patient by their treating provider, if requested by the patient. Patients undergo collection of archival tissue samples during screening and collection of blood samples throughout the study.