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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

This trial does not accept healthy volunteers

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 population

Patients over the age of 18 who will undergo neoadjuvant treatment for high-risk, early breast cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ctDNA MRD test

    Diagnostic test

    Blood and tissue samples will be collected for the ctDNA MRD test

Treatment groups

1,800 Participants
are divided into 1 treatment group
Group A: Participants with High Risk Early Breast Cancer1 intervention

Trial outcomes

Primary outcomes

1

Core biopsy tissue evaluability rate

Time frame
3 years
2

Distant Recurrence Free Interval (dRFI)

Time frame
6 years

Secondary outcomes

1

Prevalence of tumor mutations and germline variants

Time frame
6 years
2

Sensitivity/Specificity

Time frame
6 years
3

Prevalence of test positivity

Time frame
6 years
4

Pathologic complete response (pCR) status

Time frame
6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exact Sciences Corporation

Lead sponsor

NSABP Foundation Inc

Collaborator

Source ClinicalTrials.gov
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