EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
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
1,800 participants
Jun 7, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria13
- The participant or a legally authorized representative must provide study-specific informed consent prior to study entry.
- The participant must be ≥ 18 years of age.
- ECOG performance status 0 or 1.
- Histologically confirmed invasive carcinoma of the breast.
- Planned neoadjuvant therapy which includes cytotoxic chemotherapy.
- Tumor size ≥ 2.1 cm in greatest diameter.
- Unifocal or multifocal cancer documented to be the same histologic clinical subtype.
- Clinically node positive or if node negative, any one of the following:
- TNBC or HER2+ subtype
- 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.)
- 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.
- Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay.
Exclusion Criteria9
- Definitive clinical or radiologic evidence of metastatic disease.
- Initiated neoadjuvant therapy for current breast cancer diagnosis.
- Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers.
- Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment.
- Completed all therapy for any previous hematologic malignancy \< 5 years ago.
- Multicentric or contralateral invasive breast cancers.
- Known pregnancy at time of enrollment.
- Prior solid organ transplant.
- Prior allogeneic hematopoietic stem cell transplant.
Interventions
Blood and tissue samples will be collected for the ctDNA MRD test
Locations(58)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06401421