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Trial record 1 of 1 for:    NCT06230185
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ctDNA Based MRD Testing for NAC Monitoring in TNBC (B-STRONGER-I)

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ClinicalTrials.gov Identifier: NCT06230185
Recruitment Status : Recruiting
First Posted : January 30, 2024
Last Update Posted : January 30, 2024
Sponsor:
Information provided by (Responsible Party):
Pavani Chalasani, George Washington University

Study Description
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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.

Condition or disease
TNBC - Triple-Negative Breast Cancer Minimal Residual Disease

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 422 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I (B-STRONGER-I)
Actual Study Start Date : November 9, 2023
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the correlation of MRD to pCR after NAC in TNBC [ Time Frame: 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 Outcome Measures :
  1. Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC [ Time Frame: 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 Outcome Measures:
  1. Stratification based on NAC therapy regimen [ Time Frame: 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.

  2. Evaluate genomic profiles [ Time Frame: through study completion, an average of 6 months ]
    Evaluate genomic profile for specific biomarkers during neoadjuvant chemotherapy (NAC)


Biospecimen Retention:   Samples With DNA
FFPE, DNA extracted from blood, ctDNA extracted from plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patient who are scheduled to start NAC with early-stage Triple Negative Breast Cancer.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06230185


Contacts
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Contact: Ruth Stone 518 669 9232 restone@criteriuminc.com
Contact: Julee Hartwell 607-651-6273 jhartwell@criteriuminc.com

Locations
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United States, New York
Alison Stopeck Recruiting
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Personalis Inc.
Investigators
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Principal Investigator: Pavani Chalasani George Washington University
More Information
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Responsible Party: Pavani Chalasani, Director, Division of Hematology and Oncology, George Washington University
ClinicalTrials.gov Identifier: NCT06230185    
Other Study ID Numbers: 01-PS-001
B-STRONGER-I ( Other Identifier: Personalis )
First Posted: January 30, 2024    Key Record Dates
Last Update Posted: January 30, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pavani Chalasani, George Washington University:
ctDNA
Liquid Biopsy
Breast Cancer
MRD
 NAC
TNBC
NeXT Personal®
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasm, Residual
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes