EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)

Inclusion Criteria

• •1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
• •2. The participant must be ≥ 18 years of age.
• •3. ECOG performance status 0 or 1.
• •4. Histologically confirmed invasive carcinoma of the breast.
• •5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
• •6. Tumor size ≥ 2.1 cm in greatest diameter.
• •7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
• •8. Clinically node positive or if node negative, any one of the following:
• •1. TNBC or HER2+ subtype
• •2. HR+/HER2-negative with at least one of the following:
• •i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.)
• •9. Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw.
• •10. Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.