CtDNA Based MRD Testing for NAC Monitoring in TNBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorPersonalis Inc.
About this trial
A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copy number of <6).
Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
Be informed of the investigational nature of the study and all pertinent aspects of the trial.
Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
Disqualifiers
Receiving concurrent anti-neoplastic therapy for another malignancy.
Stage IV disease.
Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy.
History of allogeneic bone marrow or organ transplant.
Trial population
Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the correlation of MRD to pCR after NAC in TNBC
Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Time frame
through study completion, an average of 6 monthsSecondary outcomes
1
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
Evaluate the trajectory of changes in MRD detected by NeXT Personal CTA during neoadjuvant chemotherapy (NAC) to pathological Complete Response (pCR) or non pCR in stage I-III triple negative breast cancer (TNBC).
Time frame
through study completion, an average of 6 monthsOther outcomes
1
Stratification based on NAC therapy regimen
NeXT Personal CTA clinical accuracy may be evaluated as compared to other clinically available tests. Stratification based on NAC therapy regimen, genomic profiles and biomarker analysis.
Time frame
through study completion, an average of 6 months2
Evaluate genomic profiles
Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC)
Time frame
through study completion, an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Personalis Inc.
Lead sponsor
George Washington University
Sponsor institution
Source ClinicalTrials.gov