Minimal Residual Disease, TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
ctDNA, Liquid Biopsy, Breast Cancer, MRD, NAC, TNBC, NeXT Personal®
Brief summary
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.
Detailed description
NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status.
Interventions
None listed
Sponsors
Personalis Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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). 2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent. 3. Be informed of the investigational nature of the study and all pertinent aspects of the trial. 4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines. 5. Be ≥ 18years of age. 6. Patient who are scheduled to start NAC. 7. Be willing to provide blood samples before and during treatment. 8. Have available biopsy tissue.
Exclusion criteria
1. Receiving concurrent anti-neoplastic therapy for another malignancy. 2. Stage IV disease. 3. 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. 4. History of allogeneic bone marrow or organ transplant. 5. Blood transfusion within two weeks before collection of blood for central ctDNA testing. 6. Started systemic therapy for their breast cancer. 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the correlation of MRD to pCR after NAC in TNBC | through study completion, an average of 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC | through study completion, an average of 6 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stratification based on NAC therapy regimen | through study completion, an average of 6 months | 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. |
| Evaluate genomic profiles | through study completion, an average of 6 months | Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC) |
Countries
United States
Contacts
Primary ContactSoumya Chappidi
Backup ContactJulee Hartwell
Outcome results
None listed