EXActDNA-003 / NSABP B-64: Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease
Exact Sciences Corporation
Summary
The EXActDNA-003 study will prospectively enroll participants who are planning to undergo chemotherapy for high-risk, early breast cancer, who are willing to provide tissue and blood specimens for circulating tumor DNA (ctDNA) analysis. Participants will be followed for up to 5.5 years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…