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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Personalis Inc.
Lead sponsor
George Washington University
Sponsor institution
Source ClinicalTrials.gov