EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorExact Sciences Corporation
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ctDNA MRD test
Treatment groups
1,800 Participants
are divided into 1 treatment groupSponsors and collaborators
Exact Sciences Corporation
Lead sponsor
NSABP Foundation Inc
Collaborator
Source ClinicalTrials.gov