Clinical trial NCT06230185: CtDNA Based MRD Testing for NAC Monitoring in TNBC
Official title: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: TNBC - Triple-Negative Breast Cancer
Minimal Residual Disease
Keywords: ctDNA
Liquid Biopsy
Breast Cancer
MRD
NAC
TNBC
NeXT Personal®
Lead sponsor: Personalis Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-30
Enrollment: 422
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the correlation of MRD to pCR after NAC in TNBC
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: Stratification based on NAC therapy regimen
timeFrame: through study completion, an average of 6 months
measure: Evaluate genomic profiles
timeFrame: through study completion, an average of 6 months
Locations:
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Washington DC
country: United States
facility: George Washington University
state: District of Columbia
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center of Florida
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
state: Florida
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Ypsilanti
country: United States
facility: Trinity Health-Michigan
state: Michigan
city: Omaha
country: United States
facility: Nebraska Methodist
state: Nebraska
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
affiliation: George Washington University
name: Pavani Chalasani
role: PRINCIPAL_INVESTIGATOR
References: